ID

10541

Beschreibung

AMC-075B Enrollment Form (ENR)NCT01193842 Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With Previously Untreated HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9B26D8A0-BAA8-E8FB-E040-BB89AD4335F8

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9B26D8A0-BAA8-E8FB-E040-BB89AD4335F8

Stichworte

Versionen (3)
  1. 19.09.12 19.09.12 -
  2. 28.05.15 28.05.15 -
  3. 03.06.15 03.06.15 -
Hochgeladen am

3. Juni 2015

DOI

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AMC-075B Enrollment Form (ENR) NCT01193842

Englisch

No Instruction available.

1 Formulare  
  1. StudyEvent: AMC-075B Enrollment Form (ENR)
    1. No Instruction available.
Header Module
Beschreibung

Header Module

Projected Start Date of Treatment (mm/dd/yyyy)
Beschreibung

TreatmentProjectedBeginDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25631
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property-2
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Treating Investigator (The protocol chair may contact the investigator with questions regarding the participant enrollment and follow up)
Beschreibung

TreatingPhysicianOrParticipatingInvestigatorName

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25608
UMLS 2011AA ObjectClass
C0679823
NCI Thesaurus ObjectClass-2
C37998
UMLS 2011AA ObjectClass-2
C1518602
NCI Thesaurus ObjectClass-3
C51883
UMLS 2011AA ObjectClass-3
C1710470
NCI Thesaurus ObjectClass-4
C25936
UMLS 2011AA ObjectClass-4
C0035173
NCI Thesaurus Property
C25191
UMLS 2011AA Property
C1547383
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
Institution contact phone number (This is the phone number where the investigator can be reached directly)
Beschreibung

InstitutionContactTelephoneNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25395
UMLS 2011AA Property
C0039457
NCI Thesaurus ObjectClass-2
C25461
UMLS 2011AA ObjectClass-2
C0337611
Inclusion/exclusion Criteria
Beschreibung

Inclusion/exclusion Criteria

Inclusion Criteria
Beschreibung

AIDSMalignancyConsortiumPatientInclusionClinicalTrialEligibilityCriteria075Type

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C19707
UMLS 2011AA ObjectClass-2
C1515830
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property-2
C25532
UMLS 2011AA Property-2
C1512693
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Exclusion Criteria
Beschreibung

Exclusion Criteria

Exclusion Criteria
Beschreibung

AIDSMalignancyConsortiumPatientExclusionClinicalTrialEligibilityCriteria075Type

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C19707
UMLS 2011AA ObjectClass-2
C1515830
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property-2
C25370
UMLS 2011AA Property-2
C0680251
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Age (in years)
Beschreibung

PatientAgeYearCount

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C29848
UMLS 2011AA ValueDomain
C0439234
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
NCI Thesaurus Property
C25150
UMLS 2011AA Property
C0001779
Date Informed Consent Signed (mm/dd/yyyy)
Beschreibung

InformedConsentFormSignedDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Enrollment Stratification Data
Beschreibung

Enrollment Stratification Data

Modified Ann Arbor Stage
Beschreibung

LymphomaAnnArborLymphomaStagingSystemClassificationStage

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C3208
UMLS 2011AA ObjectClass
C0024299
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
NCI Thesaurus Property
C25161
UMLS 2011AA Property
C0008902
Is the serum LDH elevated
Beschreibung

InternationalPrognosticIndexPatientLactateDehydrogenaseAssessmentInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C20118
UMLS 2011AA ObjectClass-2
C1512894
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C25184
UMLS 2011AA Property-2
C0022917
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Ki-67 Staining Index Score
Beschreibung

LaboratoryProcedureTumorMarkerKi-67AntigenResultType

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C17220
UMLS 2011AA Property-2
C0041365
NCI Thesaurus Property-3
C17675
UMLS 2011AA Property-3
C0208804
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Hematopoietic Diagnosis
Beschreibung

HematopoieticDiseaseDiagnosisType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C13324
UMLS 2011AA ObjectClass-2
C0229601
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
IPI Stratification Score (Participant)
Beschreibung

PatientInternationalPrognosticIndexRiskStratificationType

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17102
UMLS 2011AA Property
C0035647
NCI Thesaurus Property-2
C20118
UMLS 2011AA Property-2
C1512894
NCI Thesaurus Property-3
C25689
UMLS 2011AA Property-3
C1514983
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Specimen Consent
Beschreibung

Specimen Consent

Does the participant agree to have excess specimens from this study stored for future AIDS-related research (or leftover)
Beschreibung

BloodTissueSpecimenOtherDiseasesandDisordersFutureResearchConsentInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass-2
C12434
UMLS 2011AA ObjectClass-2
C0229664
NCI Thesaurus ObjectClass-3
C19157
UMLS 2011AA ObjectClass-3
C0370003
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C15319
NCI Thesaurus Property-3
C67527
UMLS 2011AA Property-2
C0016884
NCI Thesaurus Property-4
C2991
UMLS 2011AA Property-3
C0012634
NCI Thesaurus Property-5
C25460
UMLS 2011AA Property-4
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Comments
Beschreibung

Comments

Comments
Beschreibung

ResearchCommentsText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
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Ähnliche Modelle

No Instruction available.

1 Formulare
  1. StudyEvent: AMC-075B Enrollment Form (ENR)
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header Module
TreatmentProjectedBeginDate
Item
Projected Start Date of Treatment (mm/dd/yyyy)
date
C15368 (NCI Thesaurus ObjectClass)
C25631 (NCI Thesaurus ObjectClass-2)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
TreatingPhysicianOrParticipatingInvestigatorName
Item
Treating Investigator (The protocol chair may contact the investigator with questions regarding the participant enrollment and follow up)
text
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C37998 (NCI Thesaurus ObjectClass-2)
C1518602 (UMLS 2011AA ObjectClass-2)
C51883 (NCI Thesaurus ObjectClass-3)
C1710470 (UMLS 2011AA ObjectClass-3)
C25936 (NCI Thesaurus ObjectClass-4)
C0035173 (UMLS 2011AA ObjectClass-4)
C25191 (NCI Thesaurus Property)
C1547383 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
InstitutionContactTelephoneNumber
Item
Institution contact phone number (This is the phone number where the investigator can be reached directly)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25395 (NCI Thesaurus Property)
C0039457 (UMLS 2011AA Property)
C25461 (NCI Thesaurus ObjectClass-2)
C0337611 (UMLS 2011AA ObjectClass-2)
Item Group
Inclusion/exclusion Criteria
Item
Inclusion Criteria
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19707 (NCI Thesaurus ObjectClass-2)
C1515830 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25532 (NCI Thesaurus Property-2)
C1512693 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.1
Code List
Inclusion Criteria
CL Item
Participant's Age (in Years) (Participant's age (in years))
Item Group
Exclusion Criteria
Item
Exclusion Criteria
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19707 (NCI Thesaurus ObjectClass-2)
C1515830 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property-2)
C0680251 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.2
Code List
Exclusion Criteria
CL Item
Is The Participant Hepatitis B Core Antibody Positive (Is the participant Hepatitis B core antibody positive)
PatientAgeYearCount
Item
Age (in years)
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C29848 (NCI Thesaurus ValueDomain)
C0439234 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed (mm/dd/yyyy)
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)
Item Group
Enrollment Stratification Data
Item
Modified Ann Arbor Stage
text
C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
CL.3
Code List
Modified Ann Arbor Stage
CL Item
I (I)
CL Item
Ii (II)
CL Item
Iii (III)
CL Item
Iv (IV)
InternationalPrognosticIndexPatientLactateDehydrogenaseAssessmentInd-2
Item
Is the serum LDH elevated
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20118 (NCI Thesaurus ObjectClass-2)
C1512894 (UMLS 2011AA ObjectClass-2)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25184 (NCI Thesaurus Property-2)
C0022917 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Ki-67 Staining Index Score
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17220 (NCI Thesaurus Property-2)
C0041365 (UMLS 2011AA Property-2)
C17675 (NCI Thesaurus Property-3)
C0208804 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.5
Code List
Ki-67 Staining Index Score
CL Item
< 80% (< 80%)
CL Item
>= 80% (>= 80%)
CL Item
Inconclusive (Inconclusive)
C75569 (NCI Thesaurus)
C1629507 (UMLS 2011AA)
Item
Hematopoietic Diagnosis
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C13324 (NCI Thesaurus ObjectClass-2)
C0229601 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
CL.6
Code List
Hematopoietic Diagnosis
CL Item
Activated B-cell-like Diffuse Large B-cell Lymphoma (ABC)
C36081 (NCI Thesaurus)
C1333296 (UMLS 2011AA)
CL Item
Germinal Center B-cell-like Diffuse Large B-cell Lymphoma (GCB)
C36080 (NCI Thesaurus)
C1333295 (UMLS 2011AA)
Item
IPI Stratification Score (Participant)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17102 (NCI Thesaurus Property)
C0035647 (UMLS 2011AA Property)
C20118 (NCI Thesaurus Property-2)
C1512894 (UMLS 2011AA Property-2)
C25689 (NCI Thesaurus Property-3)
C1514983 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.7
Code List
IPI Stratification Score (Participant)
CL Item
An International Prognostic Index Score Of 0 Or 1 (0 or 1)
CL Item
An International Prognostic Index Score Of 2 Or 3 (2 or 3)
BloodTissueSpecimenOtherDiseasesandDisordersFutureResearchConsentInd-2
Item
Does the participant agree to have excess specimens from this study stored for future AIDS-related research (or leftover)
boolean
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus ObjectClass-2)
C0229664 (UMLS 2011AA ObjectClass-2)
C19157 (NCI Thesaurus ObjectClass-3)
C0370003 (UMLS 2011AA ObjectClass-3)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15319 (NCI Thesaurus Property-2)
C67527 (NCI Thesaurus Property-3)
C0016884 (UMLS 2011AA Property-2)
C2991 (NCI Thesaurus Property-4)
C0012634 (UMLS 2011AA Property-3)
C25460 (NCI Thesaurus Property-5)
C1511481 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Comments
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
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