ID

24575

Description

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

Lien

https://clinicaltrials.gov/show/NCT00498043

Mots-clés

Versions (1)
  1. 07/08/2017 07/08/2017 -
Téléchargé le

7 août 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

  • Plus récent
  • Plus ancien
  • Favori
  • Plus récent
    • Plus récent
    • Plus ancien
    • Favori

    Aucun commentaire

    Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

    Eligibility Lymphoma, B-Cell NCT00498043

    Anglais

    Eligibility Lymphoma, B-Cell NCT00498043

    1 Formulaires  
    Inclusion Criteria
    Description

    Inclusion Criteria

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

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

    Type de données

    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.
    Description

    Age | Patient eligible Transplantation

    Type de données

    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.
    Description

    Patient untreated

    Type de données

    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.
    Description

    Lesion Quantity FDG-PET Scan

    Type de données

    boolean

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

    International Prognostic Index

    Type de données

    boolean

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

    Life Expectancy Minimum

    Type de données

    boolean

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

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

    Type de données

    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.
    Description

    Informed Consent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

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

    Lymphoma Histologic type Other

    Type de données

    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.
    Description

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

    Type de données

    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.
    Description

    Central Nervous System Involvement Lymphoma | Involvement meningeal Lymphoma

    Type de données

    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.
    Description

    Medical contraindication Pharmaceutical Preparations Chemotherapy Regimen

    Type de données

    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.
    Description

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

    Type de données

    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.
    Description

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

    Type de données

    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.
    Description

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

    Type de données

    boolean

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

    Disease Serious

    Type de données

    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.
    Description

    Investigational New Drugs

    Type de données

    boolean

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

    Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

    Type de données

    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.
    Description

    Adult Guardianship of Patient

    Type de données

    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
    Description

    PET Scan Perform Unsuccessful

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0032743
    UMLS CUI [1,2]
    C0884358
    UMLS CUI [1,3]
    C1272705
    Retour au début de la page

    Similar models

    Eligibility Lymphoma, B-Cell NCT00498043

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Retour au début de la page 

    Aide

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial