Eligibility Lymphoma, B-Cell NCT00498043

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StudyEvent: Eligibility
1. Eligibility Lymphoma, B-Cell NCT00498043

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Diffuse Large B-Cell Lymphoma CD20 antigen positive WHO tumor classification

Item

patient with histologically proven cd20+ diffuse large b-cell lymphoma (who classification).

boolean

C0079744 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
C1301142 (UMLS CUI [1,3])

Age | Patient eligible Transplantation

Item

age from18 to 59 years, eligible for transplant.

boolean

C0001779 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1548635 (UMLS CUI [2,2])
C0040732 (UMLS CUI [2,3])

Patient untreated

Item

patient not previously treated.

boolean

C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])

Lesion Quantity FDG-PET Scan

Item

baseline fdg-pet scan (pet0) performed before any treatment with at least one hypermetabolic lesion.

boolean

C0221198 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3641247 (UMLS CUI [1,3])

International Prognostic Index

Item

index prognostic factors (ipi) 2 or 3.

boolean

C1512894 (UMLS CUI [1])

Life Expectancy Minimum

Item

with a minimum life expectancy of 3 months.

boolean

C0023671 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])

HIV test negative Serological | Hepatitis b serology Negative | Hepatitis C serology test Negative | Exclusion Vaccination Status post

Item

negative hiv, hbv and hcv serologies £ 4 weeks (except after vaccination).

boolean

C0854048 (UMLS CUI [1,1])
C0205473 (UMLS CUI [1,2])
C0744837 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0850489 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
C2828389 (UMLS CUI [4,1])
C0042196 (UMLS CUI [4,2])
C0231290 (UMLS CUI [4,3])

Informed Consent

Item

having previously signed a written informed consent.

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Lymphoma Histologic type Other

Item

any other histological type of lymphoma.

boolean

C0024299 (UMLS CUI [1,1])
C0449574 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])

Indolent lymphoma Treated | Indolent lymphoma untreated | Diffuse Large B-Cell Lymphoma | Bone Marrow Cells Small Infiltration | Lymph nodes Cells Small Infiltration

Item

any history of treated or non-treated indolent lymphoma. however, patients not previously diagnosed and having a diffuse large b-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included.

boolean

C1334170 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1334170 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0079744 (UMLS CUI [3])
C0005953 (UMLS CUI [4,1])
C0007634 (UMLS CUI [4,2])
C0700321 (UMLS CUI [4,3])
C0332448 (UMLS CUI [4,4])
C0024204 (UMLS CUI [5,1])
C0007634 (UMLS CUI [5,2])
C0700321 (UMLS CUI [5,3])
C0332448 (UMLS CUI [5,4])

Central Nervous System Involvement Lymphoma | Involvement meningeal Lymphoma

Item

central nervous system or meningeal involvement by lymphoma.

boolean

C4050309 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
C1314939 (UMLS CUI [2,1])
C0521400 (UMLS CUI [2,2])
C0024299 (UMLS CUI [2,3])

Medical contraindication Pharmaceutical Preparations Chemotherapy Regimen

Item

contra-indication to any drug contained in the chemotherapy regimens.

boolean

C1301624 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])

Item

poor renal function (creatinin level >150 mmol/l), poor hepatic function (total bilirubin level >30 mmol/l, transaminases >2.5 maximum normal level) unless these abnormalities are related to the lymphoma.

boolean

C0232807 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0232744 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0438717 (UMLS CUI [5])
C2828389 (UMLS CUI [6,1])
C1704258 (UMLS CUI [6,2])
C0678226 (UMLS CUI [6,3])
C0024299 (UMLS CUI [6,4])

Few mature neutrophils in the bone marrow | Neutrophil count | Platelet Count measurement | Exclusion Relationship Bone marrow infiltration

Item

poor bone marrow reserve as defined by neutrophils <1.5 g/l or platelets <100 g/l, unless related to bone marrow infiltration.

boolean

C2748959 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C2828389 (UMLS CUI [4,1])
C0439849 (UMLS CUI [4,2])
C3854434 (UMLS CUI [4,3])

Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix

Item

any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ)cervical carcinoma.

boolean

C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0851140 (UMLS CUI [3])

Disease Serious

Item

any serious active disease (according to the investigator's decision).

boolean

C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])

Investigational New Drugs

Item

treatment with any investigational drug within 30 days before planned first cycle of chemotherapy.

boolean

C0013230 (UMLS CUI [1])

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

Item

pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])

Adult Guardianship of Patient

Item

adult patient under tutelage.

boolean

C0001675 (UMLS CUI [1,1])
C0680611 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])

PET Scan Perform Unsuccessful

Item

impossibility to performed a baseline pet scan (pet0) before randomization and treatment beginning

boolean

C0032743 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])

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Eligibility Lymphoma, B-Cell NCT00498043