ID

17353

Description

R-CHOP-14 Versus R-CHOP-21 and Darbepoetin Alpha in Patients Aged 60-80 Years With Diffuse Large B-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00144755

Lien

https://clinicaltrials.gov/show/NCT00144755

Mots-clés

Versions (1)
  1. 07/09/2016 07/09/2016 -
Téléchargé le

7 septembre 2016

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 :

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

Eligibility Diffuse Large Cell Lymphoma NCT00144755

Anglais

Eligibility Diffuse Large Cell Lymphoma NCT00144755

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Diffuse Large B-Cell Lymphoma Cell positive for CD20 antigen

Type de données

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C0882818
aged 66 to 80 years old. patients not previously treated. ann arbor stage ii, iii, iv. ecog performance status 0 to 2. age-adjusted ipi equal to 1, 2, or 3. with a minimum life expectancy of 3 months. negative hiv, hbv and hcv serologies test < 4 weeks (except after vaccination for hbv).
Description

Age | Patient untreated | Ann Arbor lymphoma staging system | ECOG performance status | International Prognostic Index | Life Expectancy | HIV negative | hepatitis b serology Negative | hepatitis C serology test Negative | Hepatitis B vaccination

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C0432516
UMLS CUI [4]
C1520224
UMLS CUI [5]
C1512894
UMLS CUI [6]
C0023671
UMLS CUI [7]
C0481430
UMLS CUI [8,1]
C0744837
UMLS CUI [8,2]
C1513916
UMLS CUI [9,1]
C0850489
UMLS CUI [9,2]
C1513916
UMLS CUI [10]
C0474232
having 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. 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

Lymphoma Histologic type | indolent lymphoma | Diffuse Large B-Cell Lymphoma | Cellular infiltration Bone Marrow | Cellular infiltration lymph nodes

Type de données

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0449574
UMLS CUI [2]
C1334170
UMLS CUI [3]
C0079744
UMLS CUI [4,1]
C1692321
UMLS CUI [4,2]
C0005953
UMLS CUI [5,1]
C1692321
UMLS CUI [5,2]
C0024204
central nervous system or meningeal involvement by lymphoma. contra-indication to any drug contained in the chemotherapy regimens. any serious co-morbid active disease (according to the investigator's decision).
Description

Central Nervous System Involvement with Lymphoma | Meninges Involvement with Lymphoma | Medical contraindication Pharmaceutical Preparation Related Chemotherapy Regimen | Comorbidity Serious

Type de données

boolean

Alias
UMLS CUI [1,1]
C3714787
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0024299
UMLS CUI [2,1]
C0025285
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0024299
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0439849
UMLS CUI [3,4]
C0392920
UMLS CUI [4,1]
C0009488
UMLS CUI [4,2]
C0205404
poor renal function (creatinin level > 150 micromol/l), poor hepatic function (total bilirubin level > 30mmol/l, transaminases > 2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
Description

Renal function Poor | Creatinine measurement | Liver function Poor | Bilirubin, total measurement | Transaminases increased | Abnormality Related Lymphoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0542537
UMLS CUI [2]
C0201975
UMLS CUI [3,1]
C0232741
UMLS CUI [3,2]
C0542537
UMLS CUI [4]
C0201913
UMLS CUI [5]
C0438717
UMLS CUI [6,1]
C1704258
UMLS CUI [6,2]
C0439849
UMLS CUI [6,3]
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 | Absolute neutrophil count | Platelet Count measurement | Few mature neutrophils in the bone marrow Related Bone marrow infiltration

Type de données

boolean

Alias
UMLS CUI [1]
C2748959
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4,1]
C2748959
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
uncontrolled hypertension. known hypersensitivity to erythropoietin. myocardial infarction during last 3 month, or unstable coronary disease, or uncontrolled cardiac insufficiency.
Description

Uncontrolled hypertension | Hypersensitivity Erythropoietin | Myocardial Infarction | Coronary Artery Disease Unstable | Heart failure Uncontrolled

Type de données

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0014822
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C1956346
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0018801
UMLS CUI [5,2]
C0205318
venous thrombosis or pulmonary embolism during last 3 months. treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
Description

Venous Thrombosis | Pulmonary Embolism | Investigational New Drug | Chemotherapy Regimen

Type de données

boolean

Alias
UMLS CUI [1]
C0042487
UMLS CUI [2]
C0034065
UMLS CUI [3]
C0013230
UMLS CUI [4]
C0392920
pregnant or lactating women. adult patient under tutelage.
Description

Pregnancy | Breast Feeding | Adult associated with guardianship

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0001675
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0870627
Retour au début de la page

Similar models

Eligibility Diffuse Large Cell Lymphoma NCT00144755

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Diffuse Large B-Cell Lymphoma Cell positive for CD20 antigen
Item
patients with histologically proven cd20+ diffuse large b cell lymphoma (who classification).
boolean
C0079744 (UMLS CUI [1,1])
C0882818 (UMLS CUI [1,2])
Age | Patient untreated | Ann Arbor lymphoma staging system | ECOG performance status | International Prognostic Index | Life Expectancy | HIV negative | hepatitis b serology Negative | hepatitis C serology test Negative | Hepatitis B vaccination
Item
aged 66 to 80 years old. patients not previously treated. ann arbor stage ii, iii, iv. ecog performance status 0 to 2. age-adjusted ipi equal to 1, 2, or 3. with a minimum life expectancy of 3 months. negative hiv, hbv and hcv serologies test < 4 weeks (except after vaccination for hbv).
boolean
C0001779 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0432516 (UMLS CUI [3])
C1520224 (UMLS CUI [4])
C1512894 (UMLS CUI [5])
C0023671 (UMLS CUI [6])
C0481430 (UMLS CUI [7])
C0744837 (UMLS CUI [8,1])
C1513916 (UMLS CUI [8,2])
C0850489 (UMLS CUI [9,1])
C1513916 (UMLS CUI [9,2])
C0474232 (UMLS CUI [10])
Informed consent
Item
having signed a written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Lymphoma Histologic type | indolent lymphoma | Diffuse Large B-Cell Lymphoma | Cellular infiltration Bone Marrow | Cellular infiltration lymph nodes
Item
any other histological type of lymphoma. 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
C0024299 (UMLS CUI [1,1])
C0449574 (UMLS CUI [1,2])
C1334170 (UMLS CUI [2])
C0079744 (UMLS CUI [3])
C1692321 (UMLS CUI [4,1])
C0005953 (UMLS CUI [4,2])
C1692321 (UMLS CUI [5,1])
C0024204 (UMLS CUI [5,2])
Central Nervous System Involvement with Lymphoma | Meninges Involvement with Lymphoma | Medical contraindication Pharmaceutical Preparation Related Chemotherapy Regimen | Comorbidity Serious
Item
central nervous system or meningeal involvement by lymphoma. contra-indication to any drug contained in the chemotherapy regimens. any serious co-morbid active disease (according to the investigator's decision).
boolean
C3714787 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
C0025285 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0024299 (UMLS CUI [2,3])
C1301624 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0392920 (UMLS CUI [3,4])
C0009488 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
Renal function Poor | Creatinine measurement | Liver function Poor | Bilirubin, total measurement | Transaminases increased | Abnormality Related Lymphoma
Item
poor renal function (creatinin level > 150 micromol/l), poor hepatic function (total bilirubin level > 30mmol/l, transaminases > 2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
boolean
C0232804 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0201975 (UMLS CUI [2])
C0232741 (UMLS CUI [3,1])
C0542537 (UMLS CUI [3,2])
C0201913 (UMLS CUI [4])
C0438717 (UMLS CUI [5])
C1704258 (UMLS CUI [6,1])
C0439849 (UMLS CUI [6,2])
C0024299 (UMLS CUI [6,3])
Few mature neutrophils in the bone marrow | Absolute neutrophil count | Platelet Count measurement | Few mature neutrophils in the bone marrow Related 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])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C2748959 (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])
Uncontrolled hypertension | Hypersensitivity Erythropoietin | Myocardial Infarction | Coronary Artery Disease Unstable | Heart failure Uncontrolled
Item
uncontrolled hypertension. known hypersensitivity to erythropoietin. myocardial infarction during last 3 month, or unstable coronary disease, or uncontrolled cardiac insufficiency.
boolean
C1868885 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0014822 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C1956346 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0018801 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
Venous Thrombosis | Pulmonary Embolism | Investigational New Drug | Chemotherapy Regimen
Item
venous thrombosis or pulmonary embolism during last 3 months. treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
boolean
C0042487 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
Pregnancy | Breast Feeding | Adult associated with guardianship
Item
pregnant or lactating women. adult patient under tutelage.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0001675 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0870627 (UMLS CUI [3,3])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

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