ID

24575

Descripción

A Study of Two Associations of Rituximab and Chemotherapy, With a PET-driven Strategy, in Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00498043

Link

https://clinicaltrials.gov/show/NCT00498043

Palabras clave

Versiones (1)
  1. 7/8/17 7/8/17 -
Subido en

7 de agosto de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lymphoma, B-Cell NCT00498043

Inglés

Eligibility Lymphoma, B-Cell NCT00498043

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient with histologically proven cd20+ diffuse large b-cell lymphoma (who classification).
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C3888518
UMLS CUI [1,3]
C1301142
age from18 to 59 years, eligible for transplant.
Descripción

Age | Patient eligible Transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548635
UMLS CUI [2,3]
C0040732
patient not previously treated.
Descripción

Patient untreated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
baseline fdg-pet scan (pet0) performed before any treatment with at least one hypermetabolic lesion.
Descripción

Lesion Quantity FDG-PET Scan

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C3641247
index prognostic factors (ipi) 2 or 3.
Descripción

International Prognostic Index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1512894
with a minimum life expectancy of 3 months.
Descripción

Life Expectancy Minimum

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C1524031
negative hiv, hbv and hcv serologies £ 4 weeks (except after vaccination).
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0854048
UMLS CUI [1,2]
C0205473
UMLS CUI [2,1]
C0744837
UMLS CUI [2,2]
C1513916
UMLS CUI [3,1]
C0850489
UMLS CUI [3,2]
C1513916
UMLS CUI [4,1]
C2828389
UMLS CUI [4,2]
C0042196
UMLS CUI [4,3]
C0231290
having previously signed a written informed consent.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
any other histological type of lymphoma.
Descripción

Lymphoma Histologic type Other

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0449574
UMLS CUI [1,3]
C0205394
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.
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1334170
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C1334170
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C0079744
UMLS CUI [4,1]
C0005953
UMLS CUI [4,2]
C0007634
UMLS CUI [4,3]
C0700321
UMLS CUI [4,4]
C0332448
UMLS CUI [5,1]
C0024204
UMLS CUI [5,2]
C0007634
UMLS CUI [5,3]
C0700321
UMLS CUI [5,4]
C0332448
central nervous system or meningeal involvement by lymphoma.
Descripción

Central Nervous System Involvement Lymphoma | Involvement meningeal Lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0024299
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0521400
UMLS CUI [2,3]
C0024299
contra-indication to any drug contained in the chemotherapy regimens.
Descripción

Medical contraindication Pharmaceutical Preparations Chemotherapy Regimen

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0392920
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.
Descripción

Decreased renal function | Creatinine measurement, serum | Decreased liver function | Serum total bilirubin measurement | Transaminases increased | Exclusion Abnormality Due to Lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232807
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0232744
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0438717
UMLS CUI [6,1]
C2828389
UMLS CUI [6,2]
C1704258
UMLS CUI [6,3]
C0678226
UMLS CUI [6,4]
C0024299
poor bone marrow reserve as defined by neutrophils <1.5 g/l or platelets <100 g/l, unless related to bone marrow infiltration.
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2748959
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0032181
UMLS CUI [4,1]
C2828389
UMLS CUI [4,2]
C0439849
UMLS CUI [4,3]
C3854434
any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ)cervical carcinoma.
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0851140
any serious active disease (according to the investigator's decision).
Descripción

Disease Serious

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
treatment with any investigational drug within 30 days before planned first cycle of chemotherapy.
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception
Descripción

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332268
adult patient under tutelage.
Descripción

Adult Guardianship of Patient

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001675
UMLS CUI [1,2]
C0680611
UMLS CUI [1,3]
C0030705
impossibility to performed a baseline pet scan (pet0) before randomization and treatment beginning
Descripción

PET Scan Perform Unsuccessful

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0884358
UMLS CUI [1,3]
C1272705
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Similar models

Eligibility Lymphoma, B-Cell NCT00498043

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
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])
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])
Decreased renal function | Creatinine measurement, serum | Decreased liver function | Serum total bilirubin measurement | Transaminases increased | Exclusion Abnormality Due to Lymphoma
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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