ID

27734

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT01458730

Stichworte

Versionen (1)
  1. 27.11.17 27.11.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

27. November 2017

DOI

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Creative Commons BY 4.0
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Eligibility Central Nervous System Lymphoma NCT01458730

Englisch

Eligibility Central Nervous System Lymphoma NCT01458730

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Primary central nervous system lymphoma untreated

Datentyp

boolean

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

Steroid therapy alone

Datentyp

boolean

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

Absence Lymphoma Except for Central Nervous System

Datentyp

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
Beschreibung

ECOG performance status

Datentyp

boolean

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

Age

Datentyp

boolean

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

Informed Consent | Informed Consent Guardian

Datentyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
cardiac failure > 3
Beschreibung

Heart failure New York Heart Association Classification

Datentyp

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
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods

Datentyp

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
Beschreibung

Cancer Other | Exception Disease Free of

Datentyp

boolean

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

Communicable Disease

Datentyp

boolean

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

Patients At risk Tuberculosis | Test Latent Tuberculosis

Datentyp

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
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
organ transplantation
Beschreibung

Organ Transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C0029216
serious psychiatric illness
Beschreibung

Serious mental illness

Datentyp

boolean

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

Radiotherapy to brain

Datentyp

boolean

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

Anti-Inflammatory Agents Discontinuation Unsuccessful

Datentyp

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
Beschreibung

Estimation of creatinine clearance by Cockcroft-Gault formula

Datentyp

boolean

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

Peripheral blood Granulocyte count | Peripheral blood Platelet Count measurement

Datentyp

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.
Beschreibung

Elevated total bilirubin | Aspartate aminotransferase increased | Alkaline phosphatase raised

Datentyp

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
Beschreibung

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

Datentyp

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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Ähnliche Modelle

Eligibility Central Nervous System Lymphoma NCT01458730

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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