ID

10366

Beschreibung

AMC-048 ENR (Enrollment) Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed, HIV-Associated Burkitt's Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=32E18FA2-33FA-4AF2-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=32E18FA2-33FA-4AF2-E044-0003BA3F9857

Stichworte

Versionen (4)
  1. 19.09.12 19.09.12 -
  2. 28.05.15 28.05.15 -
  3. 03.06.15 03.06.15 -
  4. 04.08.15 04.08.15 - Martin Dugas
Hochgeladen am

28. Mai 2015

DOI

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Creative Commons BY-NC 3.0 Legacy
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AMC-048 ENR (Enrollment)

Englisch

No Instruction available.

1 Formulare  
  1. StudyEvent: AMC-048 ENR (Enrollment)
    1. No Instruction available.
Header Module
Beschreibung

Header Module

Principal Investigator
Beschreibung

PrincipalInvestigatorName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C19924
UMLS 2011AA ObjectClass
C1521895
Projected Start Date of Treatment
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
Inclusion/exclusion Criteria
Beschreibung

Inclusion/exclusion Criteria

Inclusion Criteria
Beschreibung

AIDSMalignancyConsortiumPatientInclusionClinicalTrialEligibilityCriteria048Type

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

AIDSMalignancyConsortiumPatientExclusionClinicalTrialEligibilityCriteria048Type

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
Date Informed Consent Signed
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
Karnofsky Performance Status
Beschreibung

KarnofskyPerformanceStatusScore

Datentyp

text

Alias
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
Age
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
Disease Risk
Beschreibung

Disease Risk

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
Does the participant have normal LDH
Beschreibung

LaboratoryProcedureLactateDehydrogenaseResultInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C25184
UMLS 2011AA Property-2
C0022917
Does the participant have a single focus of disease that measures <10 cm
Beschreibung

SingleMalignantNeoplasmSizeIndicator

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass-2
C48440
UMLS 2011AA ObjectClass-2
C0205171
NCI Thesaurus Property
C25681
UMLS 2011AA Property
C0456389
Does the participant have intra-abdominal disease only and total resection
Beschreibung

CompleteResectedAbdominalCavityDiseaseAssessmentInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C25250
UMLS 2011AA ObjectClass
C0205197
NCI Thesaurus ObjectClass-2
C12664
UMLS 2011AA ObjectClass-2
C0230168
NCI Thesaurus ObjectClass-3
C2991
UMLS 2011AA ObjectClass-3
C0012634
NCI Thesaurus ObjectClass-4
C25654
UMLS 2011AA ObjectClass-4
C1521996
NCI Thesaurus Property
C25367
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-048 ENR (Enrollment)
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header Module
PrincipalInvestigatorName
Item
Principal Investigator
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C19924 (NCI Thesaurus ObjectClass)
C1521895 (UMLS 2011AA ObjectClass)
TreatmentProjectedBeginDate
Item
Projected Start Date of Treatment
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)
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
Date Informed Consent Obtained (Date informed consent obtained)
CL Item
Does The Participant Have A Direct Bilirubin Level Of <=2.0 Mg/dl (Does the participant have a direct bilirubin level of <=2.0 mg/dL)
CL Item
Does The Participant Have A Histologic Diagnosis Of Burkitt's Lymphoma (bl) Or Atypical Burkitt's As Per Who Criteria (Does the participant have a histologic diagnosis of Burkitt's lymphoma (BL) or atypical Burkitt's as per WHO criteria)
CL Item
Does The Participant Have A Serum Creatinine <=1.5 Mg/dl (Does the participant have a serum creatinine <=1.5 mg/dL)
CL Item
Does The Participant Have Anc >=1000/ul And Platelets >=50,000ul (unless Disease-related) (Does the participant have ANC >=1000/uL and platelets >=50,000uL (unless disease-related))
CL Item
Does The Participant Have Ast (sgot) And Alt (sgpt) <=3 X The Upper Limit Of Normal (Does the participant have AST (SGOT) and ALT (SGPT) <=3 x the upper limit of normal)
CL Item
Does The Participant Have Measurable Or Nonmeasurable Tumor Parameter(s) (Does the participant have measurable or non-measurable tumor parameter(s))
CL Item
Does The Participant Have Normal Baseline Cardiac Function Based Upon Echocardiogram Or Multigated Acquisition (muga) Blood Pool Scan With An Ejection Fraction >=50% (Does the participant have normal baseline cardiac function based upon echocardiogram or multigated acquisition (MUGA) blood pool scan with an ejection fraction >=50%)
CL Item
If The Elevated Bilirubin Is Felt To Be Secondary To Antiretroviral Therapy, Is The Participant's Total Bilirubin <=3.5 Mg/dl Provided That The Direct Bilirubin Is Normal (If the elevated bilirubin is felt to be secondary to antiretroviral therapy, is the participant's total bilirubin <=3.5 mg/dL provided that the direct bilirubin is normal)
CL Item
If The Participant Is Female Who Is Premenopausal, Did She Have A Negative Pregnancy Test (If the participant is female who is premenopausal, did she have a negative pregnancy test)
CL Item
If The Participant Is Female, Is She Of Childbearing Age And Using An Acceptable Form Of Birth Control (If the participant is female, is she of childbearing age and using an acceptable form of birth control)
CL Item
If The Participant's Creatinine Is >1.5 Mg/dl, Is The Creatinine Clearance >=60 Ml/minute (If the participant's creatinine is >1.5 mg/dL, is the creatinine clearance >=60 mL/minute)
CL Item
Is The Participant (or Their Guardian) Capable Of Providing Informed Consent (Is the participant (or their guardian) capable of providing informed consent)
CL Item
Is The Participant Hiv Positive Documented By Enzyme-linked Immunosorbent Assay [elisa] And Western Blot, Or Measurable Hiv Viral Load (Is the participant HIV positive documented by enzyme-linked immunosorbent assay [ELISA] and Western Blot, or measurable HIV viral load)
CL Item
Karnofsky Performance Status (must Be >30%) (Karnofsky performance status (must be >30%))
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
Does The Participant Have A History Of Any Malignancy For Which The Disease-free Interval Is <5 Years, Excluding Curatively Treated Cutaneous Basal Cell Or Squamous Cell Carcinoma And Carcinoma In Situ Of The Cervix Or Cutaneous Ks (Does the participant have a history of any malignancy for which the disease-free interval is <5 years, excluding curatively treated cutaneous basal cell or squamous cell carcinoma and carcinoma in situ of the cervix or cutaneous KS)
CL Item
Does The Participant Have Any Medical Illness Unrelated To Nhl, Which In The Opinion Of The Attending Physician And Principal Investigator (pi), Will Preclude Administration Of Chemotherapy Safely (Does the participant have any medical illness unrelated to NHL, which in the opinion of the attending physician and Principal Investigator (PI), will preclude administration of chemotherapy safely)
CL Item
Has The Participant Received Previous Therapy For Bl Or Atypical Bl Other Than Seven Consecutive Days Of Steroids (Has the participant received previous therapy for BL or atypical BL other than seven consecutive days of steroids)
CL Item
If The Participant Is Female, Is She Pregnant Or Breast-feeding (If the participant is female, is she pregnant or breast-feeding)
CL Item
If Yes, Will The Growth Factors Be Discontinued At Least 24 Hours Prior To Chemotherapy (If yes, will the growth factors be discontinued at least 24 hours prior to chemotherapy)
CL Item
Is The Participant Already Receiving Erythropoietin Or G-csf For Treatment Of Hiv-related Cytopenia (Is the participant already receiving erythropoietin or G-CSF for treatment of HIV-related cytopenia)
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)
KarnofskyPerformanceStatusScore
Item
Karnofsky Performance Status
text
C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
PatientAgeYearCount
Item
Age
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)
Item Group
Disease Risk
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
Ie (IE)
CL Item
Ii (II)
CL Item
Iie (IIE)
CL Item
Iii (III)
CL Item
Iiie (IIIE)
CL Item
Iiie+s (IIIE+S)
CL Item
Iiis (IIIS)
CL Item
Iv (IV)
LaboratoryProcedureLactateDehydrogenaseResultInd-2
Item
Does the participant have normal LDH
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25184 (NCI Thesaurus Property-2)
C0022917 (UMLS 2011AA Property-2)
SingleMalignantNeoplasmSizeIndicator
Item
Does the participant have a single focus of disease that measures <10 cm
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C48440 (NCI Thesaurus ObjectClass-2)
C0205171 (UMLS 2011AA ObjectClass-2)
C25681 (NCI Thesaurus Property)
C0456389 (UMLS 2011AA Property)
CompleteResectedAbdominalCavityDiseaseAssessmentInd-2
Item
Does the participant have intra-abdominal disease only and total resection
boolean
C25250 (NCI Thesaurus ObjectClass)
C0205197 (UMLS 2011AA ObjectClass)
C12664 (NCI Thesaurus ObjectClass-2)
C0230168 (UMLS 2011AA ObjectClass-2)
C2991 (NCI Thesaurus ObjectClass-3)
C0012634 (UMLS 2011AA ObjectClass-3)
C25654 (NCI Thesaurus ObjectClass-4)
C1521996 (UMLS 2011AA ObjectClass-4)
C25367 (NCI Thesaurus Property)
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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