Item
Age >= 18 years
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
Code List
Age >= 18 years
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
PatientAgeValue
Item
Age
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
Item
Untreated, histological diagnosis of CD20-positive diffuse large B cell lymphoma
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C8851 (NCI Thesaurus ObjectClass)
C0079744 (UMLS 2011AA ObjectClass)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
Code List
Untreated, histological diagnosis of CD20-positive diffuse large B cell lymphoma
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Stage II, III, or IV (Ann Arbor Staging: see Appendix II)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
Code List
Stage II, III, or IV (Ann Arbor Staging: see Appendix II)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
ECOG performance status (PS) 0, 1, or 2
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25491 (NCI Thesaurus ObjectClass)
C1512162 (UMLS 2011AA ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
Code List
ECOG performance status (PS) 0, 1, or 2
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
ECOG Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
Code List
ECOG Performance Status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
Item
The following laboratory values obtained <= 14 days prior to registration
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
The following laboratory values obtained <= 14 days prior to registration
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureEvaluationPerformedFirstDate
Item
Earliest laboratory test date (NOTE: These dates pertain to the following labs only)
date
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25509 (NCI Thesaurus ValueDomain)
C1279901 (UMLS 2011AA ValueDomain)
LaboratoryProcedureEvaluationPerformedMostRecentDate
Item
Latest laboratory test date (NOTE: These dates pertain to the following labs only)
date
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25577 (NCI Thesaurus ValueDomain)
C1513491 (UMLS 2011AA ValueDomain)
Item
Absolute neutrophil count (ANC) >=1,500/mm^3
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12533 (NCI Thesaurus Property)
C0027950 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Code List
Absolute neutrophil count (ANC) >=1,500/mm^3
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureAbsoluteNeutrophilCountResultUnspecifiedValue
Item
ANC
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63321 (NCI Thesaurus Property)
C0948762 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
Peripheral platelet count (PLT) >=100,000/mm^3
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25493 (NCI Thesaurus Property)
C0205250 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C25623 (NCI Thesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Peripheral platelet count (PLT) >=100,000/mm^3
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedurePlateletResultUnspecifiedValue
Item
Peripheral Platelet Count
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
Hemoglobin >9.0 g/dL
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
Code List
Hemoglobin >9.0 g/dL
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureHemoglobinResultUnspecifiedValue
Item
Hgb
double
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
Total bilirubin <=1.5 x ULN, or if total bilirubin is >1.5 ULN, the direct bilirubin must be normal
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C25282 (NCI Thesaurus Property)
C0332285 (UMLS 2011AA Property)
C25706 (NCI Thesaurus Property)
C1519815 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Total bilirubin <=1.5 x ULN, or if total bilirubin is >1.5 ULN, the direct bilirubin must be normal
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is total bilirubin >1.5 x ULN (this question may be answered yes or no)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
Code List
Is total bilirubin >1.5 x ULN (this question may be answered yes or no)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureDirectBilirubinMeasurementResultUnspecifiedValue
Item
Direct Bilirubin (If yes,)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C64481 (NCI Thesaurus Property)
C0201916 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureDirectBilirubinMeasurementResultUpperLimitNormalValue
Item
Direct Bilirubin ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C64481 (NCI Thesaurus Property)
C0201916 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
LaboratoryProcedureTotalBilirubinResultUnspecifiedValue
Item
Total Bilirubin (If no, <=1.5 x ULN)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureTotalBilirubinResultUpperLimitNormalValue
Item
Total Bilirubin ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Item
Alkaline phosphatase <=3 x ULN, unless evidence of direct liver involvement by lymphoma, then <=5 x ULN
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)
Code List
Alkaline phosphatase <=3 x ULN, unless evidence of direct liver involvement by lymphoma, then <=5 x ULN
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is there liver involvement (This question can be answered yes or no)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12392 (NCI Thesaurus ObjectClass)
C0023884 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
Code List
Is there liver involvement (This question can be answered yes or no)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is there liver involvement (This question can be answered yes or no)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12392 (NCI Thesaurus ObjectClass)
C0023884 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
Code List
Is there liver involvement (This question can be answered yes or no)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureAlkalinePhosphataseResultValue
Item
Alkaline Phosphatase (If yes, <=5 x ULN If no, <=3 x ULN)
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)
LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue
Item
Alkaline Phosphatase ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Item
SGOT (AST) <=3 x ULN, unless evidence of direct liver involvement by lymphoma, then <=5 x ULN
text
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C61018 (NCI Thesaurus ObjectClass)
C1883009 (UMLS 2011AA ObjectClass)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25282 (NCI Thesaurus Property)
C0332285 (UMLS 2011AA Property)
C25706 (NCI Thesaurus Property)
C1519815 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
SGOT (AST) <=3 x ULN, unless evidence of direct liver involvement by lymphoma, then <=5 x ULN
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedValue
Item
SGOT (AST) (If Yes, <=5 x ULN If No, <=3 x ULN)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
SGOT (AST) ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Item
Creatinine <= ULN (mg/dL)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Code List
Creatinine <= ULN (mg/dL)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureCreatinineResultUnspecifiedValue
Item
Creatinine
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCreatinineResultUpperLimitNormalValue
Item
Creatinine ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Item
Negative serum or urine pregnancy test done <=14 days prior to registration, for women of childbearing potential only. If not a woman of childbearing potential or male (check NA)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)
Code List
Negative serum or urine pregnancy test done <=14 days prior to registration, for women of childbearing potential only. If not a woman of childbearing potential or male (check NA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
PatientNegativePregnancyTestDate
Item
Negative pregnancy test date (If a woman of childbearing potential)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)
Item
Provide informed written consent
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C78209 (NCI Thesaurus Property)
C0085732 (UMLS 2011AA Property)
Code List
Provide informed written consent
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Willingness to return to NCCTG enrolling institution for follow-up
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Willingness to return to NCCTG enrolling institution for follow-up
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Willing to provide mandatory blood samples for correlative research purposes (see Sections 6.241, 14.0)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Code List
Willing to provide mandatory blood samples for correlative research purposes (see Sections 6.241, 14.0)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Willingness to abstain from eating grapefruit or drinking grapefruit juice for the duration of the study
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C71974 (NCI Thesaurus Property)
C0995150 (UMLS 2011AA Property)
C54264 (NCI Thesaurus Property)
C0870186 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Willingness to abstain from eating grapefruit or drinking grapefruit juice for the duration of the study
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Willingness to take everolimus orally, once daily at the same time every day either consistently with food or consistently without food
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C48387 (NCI Thesaurus Property)
C0541315 (UMLS 2011AA Property)
Code List
Willingness to take everolimus orally, once daily at the same time every day either consistently with food or consistently without food
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Measurable or assessable disease defined as at least one of the following: A lymph node or tumor mass that is >=2.0 cm in at least one dimension by CT portion of PET/CT, CT or MRI. Diffuse infiltration of an organ such as the stomach, bone marrow, peripheral blood, liver, lungs or bowel by lymphoma without a discrete mass would constitute assessable, but not measurable, disease
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C8507 (NCI Thesaurus Property)
C1513041 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Code List
Measurable or assessable disease defined as at least one of the following: A lymph node or tumor mass that is >=2.0 cm in at least one dimension by CT portion of PET/CT, CT or MRI. Diffuse infiltration of an organ such as the stomach, bone marrow, peripheral blood, liver, lungs or bowel by lymphoma without a discrete mass would constitute assessable, but not measurable, disease
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
If diabetic and taking insulin or oral anti-diabetic therapy, must have HbA1c <=8%, or a fasting serum glucose <=110% ULN (Note: The combination of everolimus with five days of concurrent prednisone at 100 mg/m^2 may cause significant hyperglycemia)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C2985 (NCI Thesaurus Property)
C0011849 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
If diabetic and taking insulin or oral anti-diabetic therapy, must have HbA1c <=8%, or a fasting serum glucose <=110% ULN (Note: The combination of everolimus with five days of concurrent prednisone at 100 mg/m^2 may cause significant hyperglycemia)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
If HIV positive, CD4 count must be >=400
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12537 (NCI Thesaurus Property)
C0039215 (UMLS 2011AA Property)
Code List
If HIV positive, CD4 count must be >=400
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown, any of the following are excluded: Pregnant women Nursing women Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the study and for 8 weeks after the last dose of study drug, by both sexes (Note: Women of childbearing potential must have a negative pregnancy test <=14 days prior to registration)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C37932 (NCI Thesaurus Property)
C0700589 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
Code List
Because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown, any of the following are excluded: Pregnant women Nursing women Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the study and for 8 weeks after the last dose of study drug, by both sexes (Note: Women of childbearing potential must have a negative pregnancy test <=14 days prior to registration)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13310 (NCI Thesaurus Property)
C0205373 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25456 (NCI Thesaurus Property)
C0205420 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive with a CD4 count of <400
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C14139 (NCI Thesaurus Property)
C0085393 (UMLS 2011AA Property)
Code List
Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive with a CD4 count of <400
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection symptomatic congestive heart failure unstable angina pectoris cardiac arrhythmia severely impaired lung function uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN (Note: Optimal glycemic control should be achieved before starting trial therapy.) psychiatric illness/social situations that would limit compliance with study requirements liver disease such as cirrhosis or severe hepatic impairment chronic active hepatitis chronic persistent hepatitis or history of hepatitis B or C
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25456 (NCI Thesaurus Property)
C0205420 (UMLS 2011AA Property)
C48932 (NCI Thesaurus Property)
C0205318 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection symptomatic congestive heart failure unstable angina pectoris cardiac arrhythmia severely impaired lung function uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN (Note: Optimal glycemic control should be achieved before starting trial therapy.) psychiatric illness/social situations that would limit compliance with study requirements liver disease such as cirrhosis or severe hepatic impairment chronic active hepatitis chronic persistent hepatitis or history of hepatitis B or C
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C15207 (NCI Thesaurus Property)
C28041 (NCI Thesaurus Property)
C1517586 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Active other malignancy, excepting non-melanotic skin cancer or carcinoma-in-situ of the cervix. If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
Code List
Active other malignancy, excepting non-melanotic skin cancer or carcinoma-in-situ of the cervix. If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
CNS Lymphoma or cerebrospinal fluid involvement with malignant lymphoma cells
text
C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C12438 (NCI Thesaurus Property)
C0927232 (UMLS 2011AA Property)
C12692 (NCI Thesaurus Property)
C0007806 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
CNS Lymphoma or cerebrospinal fluid involvement with malignant lymphoma cells
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Planned immunization with attenuated live vaccines <=7 days prior to registration or during study period (Note: Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25619 (NCI Thesaurus Property)
C1301732 (UMLS 2011AA Property)
C1920 (NCI Thesaurus ObjectClass)
C1516086 (UMLS 2011AA ObjectClass)
C15258 (NCI Thesaurus ObjectClass)
C0020971 (UMLS 2011AA ObjectClass)
Code List
Planned immunization with attenuated live vaccines <=7 days prior to registration or during study period (Note: Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Positive hepatitis B antigen (HBsAg) or hepatitis C serology (HCV) tests (Note: Hepatitis B surface antigen Hbs Ag and antibody to Hepatitis B core anti-HBc; Hepatitis C antibody. All patients must be screened prior to registration. Those patients who have evidence of chronic or acute infection with either hepatitis B or C may not be treated on this protocol)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C0021311 (NCI Metathesaurus ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
Code List
Positive hepatitis B antigen (HBsAg) or hepatitis C serology (HCV) tests (Note: Hepatitis B surface antigen Hbs Ag and antibody to Hepatitis B core anti-HBc; Hepatitis C antibody. All patients must be screened prior to registration. Those patients who have evidence of chronic or acute infection with either hepatitis B or C may not be treated on this protocol)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Currently on enzyme inducing anti-convulsants or other strong inducers (efavirenz, nevirapine, barbiturates, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, pioglitazone) or strong inhibitors of CYP3A4 (indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, saquinavir, telithromycin). (See http://medicine.iupui.edu/clinpharm/ddis/table.asp for an up-to-date list of strong inducers and inhibitors of CYP3A4.)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
Code List
Currently on enzyme inducing anti-convulsants or other strong inducers (efavirenz, nevirapine, barbiturates, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, pioglitazone) or strong inhibitors of CYP3A4 (indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, saquinavir, telithromycin). (See http://medicine.iupui.edu/clinpharm/ddis/table.asp for an up-to-date list of strong inducers and inhibitors of CYP3A4.)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
A mandatory translational research component is part of this study, patients will automatically be registered to the translational research component of this study at the time of registration. (see Sections 3.19a, 14.0, 17.11, 17.2)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25644 (NCI Thesaurus Property)
Code List
A mandatory translational research component is part of this study, patients will automatically be registered to the translational research component of this study at the time of registration. (see Sections 3.19a, 14.0, 17.11, 17.2)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Consent form signed and dated
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
Code List
Consent form signed and dated
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
Item
Authorization for use and disclosure of protected health information signed and dated (U.S.A. institutions only If not a USA institution check NA)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25178 (NCI Thesaurus Property)
C0018684 (UMLS 2011AA Property)
Code List
Authorization for use and disclosure of protected health information signed and dated (U.S.A. institutions only If not a USA institution check NA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (NA)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
HealthInsurancePortabilityandAccountabilityActTissueDonorAuthorizationDate
Item
Date of authorization (If a USA institution)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25168 (NCI Thesaurus Property)
C0040288 (UMLS 2011AA Property)
C62504 (NCI Thesaurus ObjectClass)
C0600593 (UMLS 2011AA ObjectClass)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)
Item
Treatment cannot begin prior to registration and must begin <=14 days after registration
text
C15207 (NCI Thesaurus ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C49073 (NCI Thesaurus Property)
C1707357 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Treatment cannot begin prior to registration and must begin <=14 days after registration
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Pretreatment tests/procedures must be completed <= 14 days prior to registration (see Section 4.0)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C45513 (NCI Thesaurus Property)
C1711411 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Pretreatment tests/procedures must be completed <= 14 days prior to registration (see Section 4.0)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationBeginDate
Item
Earliest pretreatment test/procedure date (NOTE: The earliest pretreatment test date must be less than or equal to the earliest laboratory test date and the latest pretreatment test date must be greater than or equal to the latest laboratory test date)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationEndDate
Item
Latest pretreatment test/procedure date
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
All required baseline symptoms (see Section 10.3) must be documented and graded
text
C15207 (NCI Thesaurus ObjectClass)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25356 (NCI Thesaurus Property)
C1301725 (UMLS 2011AA Property)
C49073 (NCI Thesaurus Property)
C1707357 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
All required baseline symptoms (see Section 10.3) must be documented and graded
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Tumor measurement/Evaluation of indicator lesion must be completed <=28 days prior to registration (Exceptions to the above dates)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Tumor measurement/Evaluation of indicator lesion must be completed <=28 days prior to registration (Exceptions to the above dates)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
PatientPriorRegistrationLaboratoryProcedureMalignantNeoplasmEligibilityDeterminationDate
Item
Exception test date
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Bone marrow aspirate and biopsy must be completed <=42 days prior to registration (Exceptions to the above dates)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Bone marrow aspirate and biopsy must be completed <=42 days prior to registration (Exceptions to the above dates)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
PatientPriorRegistrationLaboratoryProcedureBoneMarrowEligibilityDeterminationDate
Item
Exception test date
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Treatment on this protocol must commence at an NCCTG institution under the supervision of an NCCTG member physician
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25581 (NCI Thesaurus ObjectClass)
C1518419 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C61372 (NCI Thesaurus ObjectClass)
C1273870 (UMLS 2011AA ObjectClass)
Code List
Treatment on this protocol must commence at an NCCTG institution under the supervision of an NCCTG member physician
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Blood draw kit is available on site
text
C15207 (NCI Thesaurus ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25429 (NCI Thesaurus Property)
C0470187 (UMLS 2011AA Property)
C49073 (NCI Thesaurus Property)
C1707357 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Blood draw kit is available on site
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Patient has given permission to give his/her blood sample for research testing (An optional correlative research component is part of this study, there will be an option to select if the patient is to be registered onto this component Section 17.11, 17.2.)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Patient has given permission to give his/her blood sample for research testing (An optional correlative research component is part of this study, there will be an option to select if the patient is to be registered onto this component Section 17.11, 17.2.)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Patient has given permission to give his/her tissue sample for research testing (An optional correlative research component is part of this study, there will be an option to select if the patient is to be registered onto this component Section 17.11, 17.2.)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12801 (NCI Thesaurus Property)
C0040300 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C16100 (NCI Thesaurus Property)
C1511524 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Patient has given permission to give his/her tissue sample for research testing (An optional correlative research component is part of this study, there will be an option to select if the patient is to be registered onto this component Section 17.11, 17.2.)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Patient has given permission to store and use his/her sample(s) for use in future research to learn about, prevent, or treat cancer (At the time of registration/randomization, the following will also be recorded)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C67527 (NCI Thesaurus Property)
C0016884 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C16203 (NCI Thesaurus Property)
C1516654 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Patient has given permission to store and use his/her sample(s) for use in future research to learn about, prevent, or treat cancer (At the time of registration/randomization, the following will also be recorded)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Patient has given permission to store and use his/her sample(s) for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
text
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15319 (NCI Thesaurus Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Patient has given permission to store and use his/her sample(s) for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Patient has given NCCTG permission to give sample(s) to outside researchers
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C44280 (NCI Thesaurus Property)
C0205101 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25936 (NCI Thesaurus Property)
C0035173 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Patient has given NCCTG permission to give sample(s) to outside researchers
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Patient has agreed to be enrolled on N0392 (NOTE: N0392 must be open at site and offered to patient. At time of registration, willingness to participate will be recorded.)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25581 (NCI Thesaurus Property)
C1518419 (UMLS 2011AA Property)
C37948 (NCI Thesaurus Property)
C1516879 (UMLS 2011AA Property)
Code List
Patient has agreed to be enrolled on N0392 (NOTE: N0392 must be open at site and offered to patient. At time of registration, willingness to participate will be recorded.)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)