Enrollment HIV associated Burkitt Lymphoma AMC-048 NCT00392834

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1 Formulare

StudyEvent: AMC-048 ENR (Enrollment)
1. No Instruction available.

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Header Module

Item Group

Header Module

Principal Investigator

Item

Principal Investigator

text

C25191 (NCI Thesaurus ValueDomain)
C25364 (NCI Thesaurus Property)
C19924 (NCI Thesaurus ObjectClass)
C1521895 (UMLS CUI [1])

Treatment Begin Date

Item

Projected Start Date of Treatment

date

C15368 (NCI Thesaurus ObjectClass)
C25631 (NCI Thesaurus ObjectClass-2)
C25431 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C3173309 (UMLS CUI [1])

Inclusion Criteria

Item Group

Inclusion/exclusion Criteria

AIDSMalignancyConsortiumPatientInclusionClinicalTrialEligibilityCriteria048Type

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))

Exclusion Criteria

Item Group

Exclusion Criteria

AIDSMalignancyConsortiumPatientExclusionClinicalTrialEligibilityCriteria048Type

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)

Informed Consent Date

Item

Informed Consent Date

date

C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C25679 (NCI Thesaurus Property)
C2985782 (UMLS CUI [1])

Karnofsky Performance Status

Item

Karnofsky Performance Status

integer

C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0206065 (UMLS CUI [1])

Karnofsky Performance Status

Code List

Karnofsky Performance Status

CL Item

Dead (0)

CL Item

Moribund, Fatal Processes Progressing Rapidly (10)

CL Item

Normal, No Complaints, No Evidence Of Disease (100)

CL Item

Very Sick, Hospitalization Indicated. Death Not Imminent (20)

CL Item

Severely Disabled, Hospitalization Indicated. Death Not Imminent (30)

CL Item

Disabled, Requires Special Care And Assistance (40)

CL Item

Requires Considerable Assistance And Frequent Medical Care (50)

CL Item

Requires Occasional Assistance, But Is Able To Care For Most Of His/her Needs (60)

CL Item

Cares For Self, Unable To Carry On Normal Activity Or To Do Active Work (70)

CL Item

Normal Activity With Effort; Some Signs Or Symptoms Of Disease (80)

CL Item

Able To Carry On Normal Activity; Minor Signs Or Symptoms Of Disease (90)

Age

Item

Age

integer

C16960 (NCI Thesaurus ObjectClass)
C29848 (NCI Thesaurus ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS CUI [1])

Disease Risk

Item Group

Disease Risk

Ann Arbor Stage

Item

Modified Ann Arbor Stage

text

C3208 (NCI Thesaurus ObjectClass)
C16899 (NCI Thesaurus ValueDomain)
C25161 (NCI Thesaurus Property)
C0432516 (UMLS CUI [1])

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)

Comments

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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