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Information:
Fel:
ID
11740
Beskrivning
Z4032 Registration Worksheet NCT00107172 Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F20F53D3-C88B-6847-E034-0003BA3F9857
Länk
Nyckelord
Versioner (6)
- 2012-09-19 2012-09-19 -
- 2015-01-09 2015-01-09 - Martin Dugas
- 2015-06-26 2015-06-26 -
- 2015-07-25 2015-07-25 - Martin Dugas
- 2015-07-29 2015-07-29 - Martin Dugas
- 2021-09-20 2021-09-20 -
Uppladdad den
29 juli 2015
DOI
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Licens
Creative Commons BY-NC 3.0 Legacy
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Registration Worksheet NSCLC Z4032 NCT00107172
No Instruction available.
- StudyEvent: Z4032 Registration Worksheet
Similar models
No Instruction available.
- StudyEvent: Z4032 Registration Worksheet
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item
Visit
text
C25284 (NCI Thesaurus ValueDomain)
C25616 (NCI Thesaurus Property)
C19712 (NCI Thesaurus ObjectClass)
C25716 (NCI Thesaurus ObjectClass-2)
C3641100 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C19712 (NCI Thesaurus ObjectClass)
C25716 (NCI Thesaurus ObjectClass-2)
C3641100 (UMLS CUI-1)
CL Item
Registration (Registration)
C25646 (NCI Thesaurus)
C1514821 (UMLS 2011AA)
C1514821 (UMLS 2011AA)
Patient Study ID
Item
Patient ID (Pt. ID issued during registration or previously issued patient ID)
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Institution Number
Item
Institution No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
PatientRegistrationDate
Item
Registration Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
Previous study
Item
Has patient previously been registered to an ACOSOG study
boolean
C16960 (NCI Thesaurus ObjectClass)
C16124 (NCI Thesaurus ObjectClass-2)
C19712 (NCI Thesaurus Property)
CL238692 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C2242969 (UMLS CUI-1-1)
C16124 (NCI Thesaurus ObjectClass-2)
C19712 (NCI Thesaurus Property)
CL238692 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C2242969 (UMLS CUI-1-1)
Protocol ID Coordinating Group
Item
Coordinating Group Protocol No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1711341 (UMLS CUI-2)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1711341 (UMLS CUI-2)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Birth date
Item
Patient date of birth
date
C25164 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25155 (NCI Thesaurus Property)
C0421451 (UMLS CUI-1-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25155 (NCI Thesaurus Property)
C0421451 (UMLS CUI-1-1)
Item
Gender
text
C25372 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C17357 (NCI Thesaurus Property)
C0079399 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17357 (NCI Thesaurus Property)
C0079399 (UMLS CUI-1)
CL Item
Male (M)
C0086582 (UMLS CUI-1)
CL Item
Female (F)
C0015780 (UMLS CUI-1)
Item
Race (Mark all that apply)
text
C25372 (NCI Thesaurus ValueDomain)
C0034510 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17049 (NCI Thesaurus Property)
CL Item
A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)
C41261 (NCI Thesaurus)
C0007457 (UMLS 2011AA)
C0007457 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black)
C16352 (NCI Thesaurus)
C0085756 (UMLS 2011AA)
C0085756 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)
C41219 (NCI Thesaurus)
C1513907 (UMLS 2011AA)
C1513907 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)
C41260 (NCI Thesaurus)
C0078988 (UMLS 2011AA)
C0078988 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska native)
C41259 (NCI Thesaurus)
C1515945 (UMLS 2011AA)
C1515945 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
C0439673 (UMLS 2011AA)
Item
Ethnicity (Mark only one)
text
C25372 (NCI Thesaurus ValueDomain)
C0015031 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C16564 (NCI Thesaurus Property)
C0015031 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C16564 (NCI Thesaurus Property)
CL Item
A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (HISPANIC OR LATINO)
C17459 (NCI Thesaurus)
C0086409 (UMLS 2011AA)
C0086409 (UMLS 2011AA)
CL Item
A Person Not Meeting The Definition For Hispanic Or Latino. (NOT HISPANIC OR LATINO)
C41222 (NCI Thesaurus)
C1518424 (UMLS 2011AA)
C1518424 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
C0439673 (UMLS 2011AA)
Item
Method of payment (Mark all that apply)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)
CL Item
Private Insurance (Private insurance)
CL Item
Medicare (Medicare)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
C0018717 (UMLS 2011AA)
CL Item
Medicare And Private Insurance (Medicare and private insurance)
CL Item
Medicaid (Medicaid)
C0025071 (NCI Metathesaurus)
CL Item
Medicaid And Medicare (Medicaid and medicare)
CL Item
Military Or Veterans Sponsored Nos (Military or veterans sponsored NOS)
CL Item
Military Sponsored (including Champus & Tricare) (Military sponsored)
CL Item
Veterans Sponsored (Veterans sponsored)
CL Item
Self Pay (no Insurance) (Self pay)
CL Item
No Means Of Payment (no Insurance) (No means of payment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C0205394 (UMLS 2011AA)
PatientPaymentSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)
C1521902 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)
Weight
Item
Body weight
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
C0005910 (UMLS CUI-1)
Height
Item
Height
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
C0005890 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
C0005890 (UMLS CUI-1)
PatientAddressPostalCode
Item
Patient Zip Code (USA)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
C0805701 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
CanadaAddressPostalCode
Item
Postal code (Canada)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C16380 (NCI Thesaurus ObjectClass)
C0006823 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
C0805701 (UMLS 2011AA ValueDomain)
C16380 (NCI Thesaurus ObjectClass)
C0006823 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
PatientOtherCountryAddressPostalCode
Item
Other Country Postal Code (Other)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25464 (NCI Thesaurus Property-2)
C0454664 (UMLS 2011AA Property-2)
C25407 (NCI Thesaurus Property-3)
C1442065 (UMLS 2011AA Property-3)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C0030705 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25464 (NCI Thesaurus Property-2)
C0454664 (UMLS 2011AA Property-2)
C25407 (NCI Thesaurus Property-3)
C1442065 (UMLS 2011AA Property-3)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
Country of current residence
Item
Country of Residence
text
C16960 (NCI Thesaurus ObjectClass)
C3258975 (UMLS CUI-1)
C25464 (NCI Thesaurus ValueDomain)
C25407 (NCI Thesaurus Property)
C42614 (NCI Thesaurus ValueDomain-2)
C3258975 (UMLS CUI-1)
C25464 (NCI Thesaurus ValueDomain)
C25407 (NCI Thesaurus Property)
C42614 (NCI Thesaurus ValueDomain-2)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
Item
HIPAA Authorization form (OR)
text
C62504 (NCI Thesaurus ObjectClass)
C0600593 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)
C0600593 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)
CL Item
Included In Study Informed Consent (Included in Study Informed Consent)
PatientSignedDischargeMedicalRecordDate
Item
HIPAA Authorization Date (If signed as a separate form,)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C0012621 (NCI Metathesaurus Property)
C45258 (NCI Thesaurus Property-2)
C0025102 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C0030705 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C0012621 (NCI Metathesaurus Property)
C45258 (NCI Thesaurus Property-2)
C0025102 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Minor criteria met (check all that apply)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C45367 (NCI Thesaurus Property-2)
C0205165 (UMLS 2011AA Property-2)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C45367 (NCI Thesaurus Property-2)
C0205165 (UMLS 2011AA Property-2)
CL Item
Age >= 75 (Age >= 75)
CL Item
Modified Medical Research Council Dyspnea Scale >=3 (Modified Medical Research Council Dyspnea Scale >=3)
CL Item
Pco2 > 45 Mmhg (pCO2 > 45 mmHg)
CL Item
Poor Left Ventricular Function (Poor left ventricular function)
CL Item
Pulmonary Hypertension (Pulmonary hypertension)
C3120 (NCI Thesaurus)
C0020542 (UMLS 2011AA)
C0020542 (UMLS 2011AA)
CL Item
Resting Or Exercise Arterial Po2 <= 55 Mmhg Or Spo2 <= 88% (Resting or exercise arterial pO2 <= 55 mmHg or SpO2 <= 88%)
Item
Baseline Performace Status (ECOG/modified Zubrod scale)
text
C25213 (NCI Thesaurus ObjectClass)
C1442488 (UMLS 2011AA ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C1442488 (UMLS 2011AA ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
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)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
PatientSuspiciousLungNoduleInd-2
Item
Patient must have a suspicious lung nodule for clinical stage I NSCLC
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0750493 (NCI Metathesaurus Property)
C0034079 (NCI Metathesaurus Property-2)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0750493 (NCI Metathesaurus Property)
C0034079 (NCI Metathesaurus Property-2)
PatientSmallTumorInd-2
Item
Patient must have a mass <= 3 cm maximum diameter by CT size estimate: clinical stage Ia or selected Ib (i.e., with visceral pleural involvement)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25376 (NCI Thesaurus Property)
C0700321 (UMLS 2011AA Property)
CL053268 (NCI Metathesaurus Property)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25376 (NCI Thesaurus Property)
C0700321 (UMLS 2011AA Property)
CL053268 (NCI Metathesaurus Property)
PatientPriorChestComputedTomographyInd-2
Item
Patient must have a CT scan of the chest with upper abdomen within 60 days prior to pre-registration
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C0202823 (NCI Metathesaurus Property)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C0202823 (NCI Metathesaurus Property)
ECOG assessment
Item
ECOG performance status (PS) 0, 1, or 2 (Patient must have an )
boolean
C38147 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
C1512162 (UMLS CUI-1-1)
C20989 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
C1512162 (UMLS CUI-1-1)
PatientStudyCriteriaInd-2
Item
Patient must meet at least one major criteria or meet a minimum or two minor criteria as described below (Major Criteria - FEV1 <= 50%; DLCO <= 50%)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
C25466 (NCI Thesaurus Property-2)
C0243161 (UMLS 2011AA Property-2)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
C25466 (NCI Thesaurus Property-2)
C0243161 (UMLS 2011AA Property-2)
PatientThoracicRadiationTherapyInd-2
Item
Patient must have not had previous intra-thoracic radiation therapy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C13360 (NCI Thesaurus Property-2)
C0817096 (UMLS 2011AA Property-2)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C13360 (NCI Thesaurus Property-2)
C0817096 (UMLS 2011AA Property-2)
Item
Women of child-bearing potential must have negative serum or urine pregnancy test
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)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
CL Item
N/a (N/A)
PatientPriorInformedConsentInd-2
Item
Patient, or the patient's legally acceptable representative, must provide a signed and dated written informed consent PRIOR to registration and any study-related procedures being performed
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C16735 (NCI Thesaurus Property-2)
C0021430 (UMLS 2011AA Property-2)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C16735 (NCI Thesaurus Property-2)
C0021430 (UMLS 2011AA Property-2)
PatientAuthorizationConfidentialInformationInd-3
Item
Patient or the patient's legally acceptable representative must provide written authorization to allow the use and disclosure of their protected health information (NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)
C0009668 (NCI Metathesaurus Property)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)
C0009668 (NCI Metathesaurus Property)
PatientNeoplasmPersonalMedicalHistoryInd-2
Item
No prior invasive malignancies, unless disease-free for >= 5 years prior to pre-registration. (Exceptions: non-melanoma skin cancer, in-situ cancers)
boolean
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-2)
C0262926 (UMLS 2011AA Property-2)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
Item
Type of imaging (Mark all that apply)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
CL Item
Ct Scan Of Chest (CT scan of chest)
CL Item
Ct Scan Of Upper Abdomen, Including The Liver And Adrenal Glands (CT scan of upper abdomen, including the liver and adrenal glands)
DiagnosticComputedTomographyPerformedDate
Item
Date of CT Scan (chest)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C17204 (NCI Thesaurus ObjectClass)
C0040405 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25482 (NCI Thesaurus ObjectClass-2)
C0348026 (UMLS 2011AA ObjectClass-2)
C0011008 (UMLS 2011AA ValueDomain)
C17204 (NCI Thesaurus ObjectClass)
C0040405 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25482 (NCI Thesaurus ObjectClass-2)
C0348026 (UMLS 2011AA ObjectClass-2)
AbdominalCTAssessmentDate
Item
Date of Abdominal CT Assessment (upper abdomen)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C17204 (NCI Thesaurus ObjectClass)
C0040405 (UMLS 2011AA ObjectClass)
C25342 (NCI Thesaurus ObjectClass-2)
C0000726 (UMLS 2011AA ObjectClass-2)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C17204 (NCI Thesaurus ObjectClass)
C0040405 (UMLS 2011AA ObjectClass)
C25342 (NCI Thesaurus ObjectClass-2)
C0000726 (UMLS 2011AA ObjectClass-2)
PregnancyTestPerformedInd-2
Item
Pregnancy Test done
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
PatientMostRecentPregnancyTestDate
Item
Date of most recent test
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0032976 (NCI Metathesaurus Property)
C25577 (NCI Thesaurus Property)
C1513491 (UMLS 2011AA Property)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0032976 (NCI Metathesaurus Property)
C25577 (NCI Thesaurus Property)
C1513491 (UMLS 2011AA Property)
Item
Type of pregnancy test
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
C0332307 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
CL Item
Serum (Serum)
C13325 (NCI Thesaurus)
C0229671 (UMLS 2011AA)
C0229671 (UMLS 2011AA)
CL Item
Urine (Urine)
C13283 (NCI Thesaurus)
C0042036 (UMLS 2011AA)
C0042036 (UMLS 2011AA)
Item
Pregnancy Test Not Performed Reason
text
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL Item
Patient Is Male (Patient is male)
CL Item
Patient Is Female But Is Not Of Childbearing Potential (Patient is female but is not of childbearing potential)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C0205394 (UMLS 2011AA)
PregnancyLaboratoryProcedureNotPerformedSpecify
Item
Other, specify
text
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Size of Nodule on CT scan
text
C17204 (NCI Thesaurus ObjectClass)
C0040405 (UMLS 2011AA ObjectClass)
C25389 (NCI Thesaurus ObjectClass-2)
C0817096 (UMLS 2011AA ObjectClass-2)
C25681 (NCI Thesaurus Property)
C0456389 (UMLS 2011AA Property)
C3280 (NCI Thesaurus Property-2)
C0028259 (UMLS 2011AA Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C0040405 (UMLS 2011AA ObjectClass)
C25389 (NCI Thesaurus ObjectClass-2)
C0817096 (UMLS 2011AA ObjectClass-2)
C25681 (NCI Thesaurus Property)
C0456389 (UMLS 2011AA Property)
C3280 (NCI Thesaurus Property-2)
C0028259 (UMLS 2011AA Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
CL Item
0 - 1.0 Cm (0 - 1.0 cm)
CL Item
1.1 - 2.0 Cm (1.1 - 2.0 cm)
CL Item
2.1 - 3.0 Cm (2.1 - 3.0 cm)
CL Item
> 3.0 Cm (> 3.0 cm)
Item
Clinical T Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0475455 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C0205210 (UMLS CUI-2)
C25398 (NCI Thesaurus Property)
C25728 (NCI Thesaurus Property-2)
C16899 (NCI Thesaurus ValueDomain)
C0475455 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C0205210 (UMLS CUI-2)
C25398 (NCI Thesaurus Property)
C25728 (NCI Thesaurus Property-2)
C16899 (NCI Thesaurus ValueDomain)
CL Item
Tumor 3 Cm Or Less In Greatest Dimension, Surrounded By Lung Or Visceral Pleura, Invasion More Proximal Than The Lobar Bronchus, (i.e., Not In The Main Bronchus) (T1)
CL Item
Tumor With Any Of The Following Features Of Size Or Extent: More Than 3cm In Greatest Dimension; Invades The Visceral Pleura; Associated With Atelectasis Or Obstructive Pneumonitis That Extends To The Hilar Region But Does Not Involve The Entire Lung (T2)
CL Item
Tumor Of Any Size That Directly Invades Any Of The Following: Chest Wall (including Superior Sulcus Tumors), Diaphragm, Mediastinal Pleura, Parietal Pericardium; Or Tumor In The Main Bronchus Less Than 2 Cm Distal To The Carina, But Without Involvement O* (T3)
Item
Clinical N Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0456532 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C0205210 (UMLS CUI-2)
C25398 (NCI Thesaurus Property)
C25580 (NCI Thesaurus Property-2)
C16899 (NCI Thesaurus ValueDomain)
C0456532 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C0205210 (UMLS CUI-2)
C25398 (NCI Thesaurus Property)
C25580 (NCI Thesaurus Property-2)
C16899 (NCI Thesaurus ValueDomain)
CL Item
No Regional Lymph Node Metastasis (N0)
CL Item
Metastasis To Ipsilateral Peribronchial And/or Ipsilateral Hilar Lymph Nodes, And Intrapulmonary Nodes Including Involvement By Direct Extension Of The Primary Tumor (N1)
CL Item
Metastasis To Ipsilateral Mediastinal And/or Subcarinal Lymph Node(s) (N2)
Item
Clinical M Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0456533 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C0205210 (UMLS CUI-2)
C25398 (NCI Thesaurus Property)
C25727 (NCI Thesaurus Property-2)
C16899 (NCI Thesaurus ValueDomain)
C0456533 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C0205210 (UMLS CUI-2)
C25398 (NCI Thesaurus Property)
C25727 (NCI Thesaurus Property-2)
C16899 (NCI Thesaurus ValueDomain)
CL Item
No Distant Metastasis (M0)
LungForcedExpiratoryVolume1TestSpecifiedValue
Item
Forced Expiratory Volume 1 (FEV1)
float
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C38084 (NCI Thesaurus Property-2)
C0849974 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0205369 (UMLS 2011AA ValueDomain-2)
C0024109 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C38084 (NCI Thesaurus Property-2)
C0849974 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0205369 (UMLS 2011AA ValueDomain-2)
LungForcedExpiratoryVolume1TestPercentageValue
Item
Forced Expiratory Volume 1 (%Predicted FEV1)
float
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C38084 (NCI Thesaurus Property-2)
C0849974 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C0024109 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C38084 (NCI Thesaurus Property-2)
C0849974 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Carbon Monoxide Diffusing Capability Test
Item
Carbon Monoxide Diffusion (DLCO)
float
C12468 (NCI Thesaurus ObjectClass)
C20989 (NCI Thesaurus Property)
C38083 (NCI Thesaurus Property-2)
C25613 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C16238 (NCI Thesaurus ValueDomain-3)
C1516251 (UMLS CUI-1-1)
C20989 (NCI Thesaurus Property)
C38083 (NCI Thesaurus Property-2)
C25613 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C16238 (NCI Thesaurus ValueDomain-3)
C1516251 (UMLS CUI-1-1)
VitalLungCapacityTestPercentageValue
Item
Forced Vital Capacity (% predicted)
float
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C18003 (NCI Thesaurus ObjectClass-2)
C0442732 (UMLS 2011AA ObjectClass-2)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25443 (NCI Thesaurus Property-2)
C1516240 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C0024109 (UMLS 2011AA ObjectClass)
C18003 (NCI Thesaurus ObjectClass-2)
C0442732 (UMLS 2011AA ObjectClass-2)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25443 (NCI Thesaurus Property-2)
C1516240 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Item
Did the Investigator sign the CRF indicating review of all data and certifying data are accurate and complete to the best of their knowledge
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25936 (NCI Thesaurus Property)
C0035173 (UMLS 2011AA Property)
C42729 (NCI Thesaurus Property-2)
C1552617 (UMLS 2011AA Property-2)
C1512698 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25936 (NCI Thesaurus Property)
C0035173 (UMLS 2011AA Property)
C42729 (NCI Thesaurus Property-2)
C1552617 (UMLS 2011AA Property-2)
Code List
Did the Investigator sign the CRF indicating review of all data and certifying data are accurate and complete to the best of their knowledge
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
Investigator Signature Date
Item
Date of Investigator Signature
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
Responsible Person Signature
Item
Completed by
text
C25704 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C25678 (NCI Thesaurus Property)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C25678 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)