ID

17350

Beschrijving

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

Trefwoorden

Versies (3)
  1. 07-09-16 07-09-16 -
  2. 07-09-16 07-09-16 -
  3. 07-09-16 07-09-16 -
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7 september 2016

DOI

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Licentie

Creative Commons BY-NC 3.0
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Eligibility Diffuse Large Cell Lymphoma NCT00140660

Engels

Eligibility Diffuse Large Cell Lymphoma NCT00140660

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Diffuse Large B-Cell Lymphoma Cell positive for CD20 antigen

Datatype

boolean

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

Age

Datatype

boolean

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

Patient untreated

Datatype

boolean

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

Ann Arbor lymphoma staging system

Datatype

boolean

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

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
normal ldh.
Beschrijving

Blood lactate dehydrogenase normal

Datatype

boolean

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

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

Datatype

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.
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

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.
Beschrijving

Lymphoma Histologic type | indolent lymphoma | Diffuse Large B-Cell Lymphoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0449574
UMLS CUI [2]
C1334170
UMLS CUI [3]
C0079744
central nervous system or meningeal involvement by lymphoma.
Beschrijving

Central Nervous System Involvement with Lymphoma | Meninges Involvement with Lymphoma

Datatype

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.
Beschrijving

Medical contraindication Pharmaceutical Preparation Related Chemotherapy Regimen

Datatype

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).
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

boolean

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

Disease Serious

Datatype

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.
Beschrijving

Investigational New Drugs | Chemotherapy

Datatype

boolean

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

Pregnancy | Breast Feeding

Datatype

boolean

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

Adult | guardianship

Datatype

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0870627
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Similar models

Eligibility Diffuse Large Cell Lymphoma NCT00140660

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
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])
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 | guardianship
Item
adult patient under tutelage.
boolean
C0001675 (UMLS CUI [1])
C0870627 (UMLS CUI [2])
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