ID

27733

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01011920

Nyckelord

Versioner (1)
  1. 2017-11-27 2017-11-27 -
Rättsinnehavare

See clinicaltrials.gov

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27 november 2017

DOI

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Creative Commons BY 4.0
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Eligibility Central Nervous System Lymphoma NCT01011920

Engelsk

Eligibility Central Nervous System Lymphoma NCT01011920

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Lymphoma, Non-Hodgkin

Datatyp

boolean

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

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Measurable lesion Quantity

Datatyp

boolean

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

Patients untreated | Steroid therapy

Datatyp

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).
Beskrivning

Age | ECOG performance status

Datatyp

boolean

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

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

Datatyp

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.
Beskrivning

Sexually active Childbearing Potential Contraceptive methods

Datatyp

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.
Beskrivning

Absence Condition Preventing Protocol Compliance

Datatyp

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.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Lymphoma Except for Central Nervous System

Datatyp

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.
Beskrivning

Non-Hodgkin Lymphoma Previous

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Hepatitis B surface antigen positive | Serology positive Hepatitis C virus

Datatyp

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.
Beskrivning

HIV Infection | Organ Transplantation | Immunodeficiency

Datatyp

boolean

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

Investigational New Drugs

Datatyp

boolean

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

Pregnancy | Breast Feeding

Datatyp

boolean

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

Contraceptive methods Unwilling

Datatyp

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).
Beskrivning

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

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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