ID

17354

Description

ACVBP Versus ACVBP Plus Rituximab in Low Risk Localized Diffuse Large B-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00140660

Link

https://clinicaltrials.gov/show/NCT00140660

Keywords

Versions (3)
  1. 9/7/16 9/7/16 -
  2. 9/7/16 9/7/16 -
  3. 9/7/16 9/7/16 -
Uploaded on

September 7, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Diffuse Large Cell Lymphoma NCT00140660

English

Eligibility Diffuse Large Cell Lymphoma NCT00140660

1 forms  
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 Cell positive for CD20 antigen

Data type

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C0882818
age from 18 to 65 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient not previously treated.
Description

Patient untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
ann arbor stage i or ii.
Description

Ann Arbor lymphoma staging system

Data type

boolean

Alias
UMLS CUI [1]
C0432516
ecog performance status < 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
normal ldh.
Description

Blood lactate dehydrogenase normal

Data type

boolean

Alias
UMLS CUI [1]
C0853788
negative hiv, hbv and hcv serologies 4 weeks (except after vaccination).
Description

HIV negative | hepatitis b serology Negative | hepatitis C serology test Negative | Vaccination

Data type

boolean

Alias
UMLS CUI [1]
C0481430
UMLS CUI [2,1]
C0744837
UMLS CUI [2,2]
C1513916
UMLS CUI [3,1]
C0850489
UMLS CUI [3,2]
C1513916
UMLS CUI [4]
C0042196
having previously signed a written informed consent.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any other histological type of lymphoma. vany 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 lymph node may be included.
Description

Lymphoma Histologic type | indolent lymphoma | Diffuse Large B-Cell Lymphoma | Cellular infiltration Lymph nodes

Data type

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]
C0024204
central nervous system or meningeal involvement by lymphoma.
Description

Central Nervous System Involvement with Lymphoma | Meninges Involvement with Lymphoma

Data type

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

Medical contraindication Pharmaceutical Preparation Related Chemotherapy Regimen

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0439849
UMLS CUI [1,4]
C0392920
poor renal function (creatinin level >150 mmol/l), poor hepatic function (total bilirubin level >30 mmol/l, transaminases >2.5 maximum normal level).
Description

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

Data type

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
poor bone marrow reserve as defined by neutrophils < 1.5 g/l or platelets < 100 g/l.
Description

Few mature neutrophils in the bone marrow | Absolute neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C2748959
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
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

Data type

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

Data type

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 and during the study.
Description

Investigational New Drugs | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0392920
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
adult patient under tutelage.
Description

Adult Associated with guardianship

Data type

boolean

Alias
UMLS CUI [1,1]
C0001675
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0870627
Back to the top of the page

Similar models

Eligibility Diffuse Large Cell Lymphoma NCT00140660

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diffuse Large B-Cell Lymphoma Cell positive for CD20 antigen
Item
patient with histologically proven cd20+ diffuse large b-cell lymphoma (who classification).
boolean
C0079744 (UMLS CUI [1,1])
C0882818 (UMLS CUI [1,2])
Age
Item
age from 18 to 65 years.
boolean
C0001779 (UMLS CUI [1])
Patient untreated
Item
patient not previously treated.
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Ann Arbor lymphoma staging system
Item
ann arbor stage i or ii.
boolean
C0432516 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status < 2.
boolean
C1520224 (UMLS CUI [1])
Blood lactate dehydrogenase normal
Item
normal ldh.
boolean
C0853788 (UMLS CUI [1])
HIV negative | hepatitis b serology Negative | hepatitis C serology test Negative | Vaccination
Item
negative hiv, hbv and hcv serologies 4 weeks (except after vaccination).
boolean
C0481430 (UMLS CUI [1])
C0744837 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0850489 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
C0042196 (UMLS CUI [4])
Informed consent
Item
having previously 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 Lymph nodes
Item
any other histological type of lymphoma. vany 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 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])
C0024204 (UMLS CUI [4,2])
Central Nervous System Involvement with Lymphoma | Meninges Involvement with Lymphoma
Item
central nervous system or meningeal involvement by lymphoma.
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])
Medical contraindication Pharmaceutical Preparation Related Chemotherapy Regimen
Item
contra-indication to any drug contained in the chemotherapy regimens.
boolean
C1301624 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0392920 (UMLS CUI [1,4])
Renal function Poor | Creatinine measurement | Liver function Poor | Bilirubin, total measurement | Transaminases increased
Item
poor renal function (creatinin level >150 mmol/l), poor hepatic function (total bilirubin level >30 mmol/l, transaminases >2.5 maximum normal level).
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])
Few mature neutrophils in the bone marrow | Absolute neutrophil count | Platelet Count measurement
Item
poor bone marrow reserve as defined by neutrophils < 1.5 g/l or platelets < 100 g/l.
boolean
C2748959 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [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 | Chemotherapy
Item
treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
boolean
C0013230 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Adult Associated with guardianship
Item
adult patient under tutelage.
boolean
C0001675 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0870627 (UMLS CUI [1,3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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