ID

27734

Beskrivning

Nordic Study in Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01458730

Länk

https://clinicaltrials.gov/show/NCT01458730

Nyckelord

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

See clinicaltrials.gov

Uppladdad den

27 november 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Central Nervous System Lymphoma NCT01458730

Engelsk

Eligibility Central Nervous System Lymphoma NCT01458730

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologically verified primary central nervous system lymphoma no prior pcnsl treatment.
Beskrivning

Primary central nervous system lymphoma untreated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0280803
UMLS CUI [1,2]
C0332155
patients treated with steroids alone are eligible
Beskrivning

Steroid therapy alone

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0205171
no signs of lymphoma outside the cns
Beskrivning

Absence Lymphoma Except for Central Nervous System

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0024299
UMLS CUI [1,3]
C0332300
UMLS CUI [1,4]
C3714787
ecog performance status 0-4
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
age > 17 and < 76 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent from the patient or guardian
Beskrivning

Informed Consent | Informed Consent Guardian

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
cardiac failure > 3
Beskrivning

Heart failure New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
pregnancy or lactation. women of childbearing potential are requested to use an effective method of contraception to avoid pregnancy for a period from entry to the study and at least 3 months after the last study medication
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
previous malignancy unless disease free for at least five years
Beskrivning

Cancer Other | Exception Disease Free of

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332296
active infection.
Beskrivning

Communicable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
regarding tuberculosis, patients at risk should be tested for latent tb according local practice at each treating centre.
Beskrivning

Patients At risk Tuberculosis | Test Latent Tuberculosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0041296
UMLS CUI [2,1]
C0039593
UMLS CUI [2,2]
C1609538
positive hiv status
Beskrivning

HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
organ transplantation
Beskrivning

Organ Transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C0029216
serious psychiatric illness
Beskrivning

Serious mental illness

Datatyp

boolean

Alias
UMLS CUI [1]
C3841614
prior radiotherapy to the brain
Beskrivning

Radiotherapy to brain

Datatyp

boolean

Alias
UMLS CUI [1]
C0948319
concomitant anti-inflammatory medication that cannot be discontinued
Beskrivning

Anti-Inflammatory Agents Discontinuation Unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003209
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1272705
creatinine clearance < 60 ml/minute calculated by cockcroft and gault formula
Beskrivning

Estimation of creatinine clearance by Cockcroft-Gault formula

Datatyp

boolean

Alias
UMLS CUI [1]
C2711451
peripheral blood count with granulocytes <1.5 x 109l or platelets < 100 x 109l
Beskrivning

Peripheral blood Granulocyte count | Peripheral blood Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0229664
UMLS CUI [1,2]
C0857490
UMLS CUI [2,1]
C0229664
UMLS CUI [2,2]
C0032181
serum bilirubin >1.5 times or asat and alkaline phosphatase >2 times upper limits of normal.
Beskrivning

Elevated total bilirubin | Aspartate aminotransferase increased | Alkaline phosphatase raised

Datatyp

boolean

Alias
UMLS CUI [1]
C0741494
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151849
known anaphylaxis or ige-mediated hypersensitivity to murine protein or any component of rituximab excludes patients from rituximab treatment, but not from the remaining part of the study
Beskrivning

Anaphylaxis murine protein | Immediate hypersensitivity murine protein | Anaphylaxis rituximab Component | Immediate hypersensitivity rituximab Component | rituximab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C1699668
UMLS CUI [2,1]
C0020523
UMLS CUI [2,2]
C1699668
UMLS CUI [3,1]
C0002792
UMLS CUI [3,2]
C0393022
UMLS CUI [3,3]
C1705248
UMLS CUI [4,1]
C0020523
UMLS CUI [4,2]
C0393022
UMLS CUI [4,3]
C1705248
UMLS CUI [5]
C0393022
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Similar models

Eligibility Central Nervous System Lymphoma NCT01458730

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Primary central nervous system lymphoma untreated
Item
pathologically verified primary central nervous system lymphoma no prior pcnsl treatment.
boolean
C0280803 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Steroid therapy alone
Item
patients treated with steroids alone are eligible
boolean
C0149783 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
Absence Lymphoma Except for Central Nervous System
Item
no signs of lymphoma outside the cns
boolean
C0332197 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
C0332300 (UMLS CUI [1,3])
C3714787 (UMLS CUI [1,4])
ECOG performance status
Item
ecog performance status 0-4
boolean
C1520224 (UMLS CUI [1])
Age
Item
age > 17 and < 76 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Informed Consent Guardian
Item
written informed consent from the patient or guardian
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Heart failure New York Heart Association Classification
Item
cardiac failure > 3
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods
Item
pregnancy or lactation. women of childbearing potential are requested to use an effective method of contraception to avoid pregnancy for a period from entry to the study and at least 3 months after the last study medication
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Cancer Other | Exception Disease Free of
Item
previous malignancy unless disease free for at least five years
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
Communicable Disease
Item
active infection.
boolean
C0009450 (UMLS CUI [1])
Patients At risk Tuberculosis | Test Latent Tuberculosis
Item
regarding tuberculosis, patients at risk should be tested for latent tb according local practice at each treating centre.
boolean
C0030705 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0041296 (UMLS CUI [1,3])
C0039593 (UMLS CUI [2,1])
C1609538 (UMLS CUI [2,2])
HIV Seropositivity
Item
positive hiv status
boolean
C0019699 (UMLS CUI [1])
Organ Transplantation
Item
organ transplantation
boolean
C0029216 (UMLS CUI [1])
Serious mental illness
Item
serious psychiatric illness
boolean
C3841614 (UMLS CUI [1])
Radiotherapy to brain
Item
prior radiotherapy to the brain
boolean
C0948319 (UMLS CUI [1])
Anti-Inflammatory Agents Discontinuation Unsuccessful
Item
concomitant anti-inflammatory medication that cannot be discontinued
boolean
C0003209 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
creatinine clearance < 60 ml/minute calculated by cockcroft and gault formula
boolean
C2711451 (UMLS CUI [1])
Peripheral blood Granulocyte count | Peripheral blood Platelet Count measurement
Item
peripheral blood count with granulocytes <1.5 x 109l or platelets < 100 x 109l
boolean
C0229664 (UMLS CUI [1,1])
C0857490 (UMLS CUI [1,2])
C0229664 (UMLS CUI [2,1])
C0032181 (UMLS CUI [2,2])
Elevated total bilirubin | Aspartate aminotransferase increased | Alkaline phosphatase raised
Item
serum bilirubin >1.5 times or asat and alkaline phosphatase >2 times upper limits of normal.
boolean
C0741494 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151849 (UMLS CUI [3])
Anaphylaxis murine protein | Immediate hypersensitivity murine protein | Anaphylaxis rituximab Component | Immediate hypersensitivity rituximab Component | rituximab
Item
known anaphylaxis or ige-mediated hypersensitivity to murine protein or any component of rituximab excludes patients from rituximab treatment, but not from the remaining part of the study
boolean
C0002792 (UMLS CUI [1,1])
C1699668 (UMLS CUI [1,2])
C0020523 (UMLS CUI [2,1])
C1699668 (UMLS CUI [2,2])
C0002792 (UMLS CUI [3,1])
C0393022 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
C0020523 (UMLS CUI [4,1])
C0393022 (UMLS CUI [4,2])
C1705248 (UMLS CUI [4,3])
C0393022 (UMLS CUI [5])
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