ID

27733

Description

Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01011920

Lien

https://clinicaltrials.gov/show/NCT01011920

Mots-clés

Versions (1)
  1. 27/11/2017 27/11/2017 -
Détendeur de droits

See clinicaltrials.gov

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27 novembre 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Central Nervous System Lymphoma NCT01011920

Anglais

Eligibility Central Nervous System Lymphoma NCT01011920

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological or cytological assessed diagnosis of non-hodgkin's lymphoma.
Description

Lymphoma, Non-Hodgkin

Type de données

boolean

Alias
UMLS CUI [1]
C0024305
diagnostic sample obtained by stereotactic or surgical biopsy, cerebrospinal fluid (csf) cytology examination or vitrectomy.
Description

Specimen Stereotactic Biopsy | Specimen Surgical biopsy | Cerebrospinal Fluid Cytology procedure | Cerebrospinal Fluid Vitrectomy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1711202
UMLS CUI [2,1]
C0370003
UMLS CUI [2,2]
C0565118
UMLS CUI [3,1]
C0007806
UMLS CUI [3,2]
C1305671
UMLS CUI [4,1]
C0007806
UMLS CUI [4,2]
C0042903
disease exclusively localized into the central nervous system, csf, cranial nerves or eyes.
Description

Disease localization Central Nervous System | Disease loclization Cerebrospinal Fluid | Disease localization Cranial Nerves | Disease localization Eyes

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0475264
UMLS CUI [1,3]
C3714787
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0475264
UMLS CUI [2,3]
C0007806
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0475264
UMLS CUI [3,3]
C0010268
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0475264
UMLS CUI [4,3]
C0015392
at least one measurable lesion.
Description

Measurable lesion Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
previously untreated patients (previous or ongoing steroid therapy admitted).
Description

Patients untreated | Steroid therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0149783
age 18-65 years (with ecog performance status 0-3) or 66-70 (with ecog performance status 0-2).
Description

Age | ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1520224
adequate bone marrow, renal, cardiac, and hepatic function.
Description

Bone Marrow function | Renal function | Cardiac function | Liver function

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232164
UMLS CUI [4]
C0232741
sexually active patients of childbearing potential agreeing in implementing adequate contraceptive measures during study participation.
Description

Sexually active Childbearing Potential Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1,1]
C0241028
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0700589
absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Description

Absence Condition Preventing Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0348080
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C0525058
patient-signed informed consent obtained before registration.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with lymphomatous lesions outside the cns.
Description

Lymphoma Except for Central Nervous System

Type de données

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C3714787
patients with a previous non-hodgkin lymphoma at any time.
Description

Non-Hodgkin Lymphoma Previous

Type de données

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C0205156
previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix, carcinoma of the skin or other cancers without evidence of disease at least from 5 years.
Description

Cancer Other | Exception Cured Surgical Carcinoma in situ of uterine cervix | Exception Cured Surgical Skin carcinoma | Exception Cured Surgical Malignant Neoplasms | Disease Free of

Type de données

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1880198
UMLS CUI [2,3]
C0543467
UMLS CUI [2,4]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1880198
UMLS CUI [3,3]
C0543467
UMLS CUI [3,4]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1880198
UMLS CUI [4,3]
C0543467
UMLS CUI [4,4]
C0006826
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0332296
hbsag and hcv positivity.
Description

Hepatitis B surface antigen positive | Serology positive Hepatitis C virus

Type de données

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0220847
hiv infection, previous organ transplantation or other clinically evident form of immunodeficiency.
Description

HIV Infection | Organ Transplantation | Immunodeficiency

Type de données

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0029216
UMLS CUI [3]
C0021051
concurrent treatment with other experimental drugs.
Description

Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
concurrent pregnancy or lactation.
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients not agreeing to take adequate contraceptive measures during the study.
Description

Contraceptive methods Unwilling

Type de données

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
symptomatic coronary artery disease, cardiac arrhythmias uncontrolled with medication or myocardial infarction within the last 6 months (new york heart association class iii or iv heart disease).
Description

Coronary Artery Disease Symptomatic | Cardiac Arrhythmia Uncontrolled | Myocardial Infarction | Heart Disease New York Heart Association Classification

Type de données

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C1275491
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Similar models

Eligibility Central Nervous System Lymphoma NCT01011920

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Lymphoma, Non-Hodgkin
Item
histological or cytological assessed diagnosis of non-hodgkin's lymphoma.
boolean
C0024305 (UMLS CUI [1])
Specimen Stereotactic Biopsy | Specimen Surgical biopsy | Cerebrospinal Fluid Cytology procedure | Cerebrospinal Fluid Vitrectomy
Item
diagnostic sample obtained by stereotactic or surgical biopsy, cerebrospinal fluid (csf) cytology examination or vitrectomy.
boolean
C0370003 (UMLS CUI [1,1])
C1711202 (UMLS CUI [1,2])
C0370003 (UMLS CUI [2,1])
C0565118 (UMLS CUI [2,2])
C0007806 (UMLS CUI [3,1])
C1305671 (UMLS CUI [3,2])
C0007806 (UMLS CUI [4,1])
C0042903 (UMLS CUI [4,2])
Disease localization Central Nervous System | Disease loclization Cerebrospinal Fluid | Disease localization Cranial Nerves | Disease localization Eyes
Item
disease exclusively localized into the central nervous system, csf, cranial nerves or eyes.
boolean
C0012634 (UMLS CUI [1,1])
C0475264 (UMLS CUI [1,2])
C3714787 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0475264 (UMLS CUI [2,2])
C0007806 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0475264 (UMLS CUI [3,2])
C0010268 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0475264 (UMLS CUI [4,2])
C0015392 (UMLS CUI [4,3])
Measurable lesion Quantity
Item
at least one measurable lesion.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Patients untreated | Steroid therapy
Item
previously untreated patients (previous or ongoing steroid therapy admitted).
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0149783 (UMLS CUI [2])
Age | ECOG performance status
Item
age 18-65 years (with ecog performance status 0-3) or 66-70 (with ecog performance status 0-2).
boolean
C0001779 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Bone Marrow function | Renal function | Cardiac function | Liver function
Item
adequate bone marrow, renal, cardiac, and hepatic function.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232164 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
Sexually active Childbearing Potential Contraceptive methods
Item
sexually active patients of childbearing potential agreeing in implementing adequate contraceptive measures during study participation.
boolean
C0241028 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Absence Condition Preventing Protocol Compliance
Item
absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
boolean
C0332197 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
Informed Consent
Item
patient-signed informed consent obtained before registration.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Lymphoma Except for Central Nervous System
Item
patients with lymphomatous lesions outside the cns.
boolean
C0024299 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C3714787 (UMLS CUI [1,3])
Non-Hodgkin Lymphoma Previous
Item
patients with a previous non-hodgkin lymphoma at any time.
boolean
C0024305 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Cancer Other | Exception Cured Surgical Carcinoma in situ of uterine cervix | Exception Cured Surgical Skin carcinoma | Exception Cured Surgical Malignant Neoplasms | Disease Free of
Item
previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix, carcinoma of the skin or other cancers without evidence of disease at least from 5 years.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1880198 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C0851140 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C1880198 (UMLS CUI [3,2])
C0543467 (UMLS CUI [3,3])
C0699893 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C1880198 (UMLS CUI [4,2])
C0543467 (UMLS CUI [4,3])
C0006826 (UMLS CUI [4,4])
C0012634 (UMLS CUI [5,1])
C0332296 (UMLS CUI [5,2])
Hepatitis B surface antigen positive | Serology positive Hepatitis C virus
Item
hbsag and hcv positivity.
boolean
C0149709 (UMLS CUI [1])
C0242089 (UMLS CUI [2,1])
C0220847 (UMLS CUI [2,2])
HIV Infection | Organ Transplantation | Immunodeficiency
Item
hiv infection, previous organ transplantation or other clinically evident form of immunodeficiency.
boolean
C0019693 (UMLS CUI [1])
C0029216 (UMLS CUI [2])
C0021051 (UMLS CUI [3])
Investigational New Drugs
Item
concurrent treatment with other experimental drugs.
boolean
C0013230 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
concurrent pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraceptive methods Unwilling
Item
patients not agreeing to take adequate contraceptive measures during the study.
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Coronary Artery Disease Symptomatic | Cardiac Arrhythmia Uncontrolled | Myocardial Infarction | Heart Disease New York Heart Association Classification
Item
symptomatic coronary artery disease, cardiac arrhythmias uncontrolled with medication or myocardial infarction within the last 6 months (new york heart association class iii or iv heart disease).
boolean
C1956346 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0003811 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0018799 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
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