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ID

24575

Descrição

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

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Versões (1)
  1. 07/08/2017 07/08/2017 -
Transferido a

7 de agosto de 2017

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Lymphoma, B-Cell NCT00498043

    Inglês

    Eligibility Lymphoma, B-Cell NCT00498043

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

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

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

    Tipo de dados

    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.
    Descrição

    Age | Patient eligible Transplantation

    Tipo de dados

    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.
    Descrição

    Patient untreated

    Tipo de dados

    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.
    Descrição

    Lesion Quantity FDG-PET Scan

    Tipo de dados

    boolean

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

    International Prognostic Index

    Tipo de dados

    boolean

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

    Life Expectancy Minimum

    Tipo de dados

    boolean

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

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

    Tipo de dados

    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.
    Descrição

    Informed Consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Descrição

    Exclusion Criteria

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

    Lymphoma Histologic type Other

    Tipo de dados

    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.
    Descrição

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

    Tipo de dados

    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.
    Descrição

    Central Nervous System Involvement Lymphoma | Involvement meningeal Lymphoma

    Tipo de dados

    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.
    Descrição

    Medical contraindication Pharmaceutical Preparations Chemotherapy Regimen

    Tipo de dados

    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.
    Descrição

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

    Tipo de dados

    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.
    Descrição

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

    Tipo de dados

    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.
    Descrição

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

    Tipo de dados

    boolean

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

    Disease Serious

    Tipo de dados

    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.
    Descrição

    Investigational New Drugs

    Tipo de dados

    boolean

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

    Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

    Tipo de dados

    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.
    Descrição

    Adult Guardianship of Patient

    Tipo de dados

    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
    Descrição

    PET Scan Perform Unsuccessful

    Tipo de dados

    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 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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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