ID

13963

Description

Whole Brain Irradiation in Primary Central Nervous System (CNS) Lymphoma (PCNSL); ODM derived from: https://clinicaltrials.gov/show/NCT00153530

Link

https://clinicaltrials.gov/show/NCT00153530

Keywords

Versions (1)
  1. 3/20/16 3/20/16 -
Uploaded on

March 20, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Central Nervous System Lymphoma NCT00153530

English

Eligibility Central Nervous System Lymphoma NCT00153530

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically/immunocytologically confirmed primary non-hodgkin's lymphoma of the cns. a central reference pathological report will be made on inclusion into the study (prof. dr. pietsch, reference center for brain tumors of the german society for neuropathology and neuroanatomy, institute of neuropathology of the bonn university hospital). histological diagnosis is usually performed by preferential stereotactic biopsy of suspicious lesions in the brain or spinal cord. the diagnosis from cerebrospinal fluid (csf) requires the detection of malignant lymphocytes according to cytological and immunocytological criteria. there should be no more than 2 weeks between establishing the diagnosis and inclusion in the study. the availability of the reference pathological report is not absolutely necessary for inclusion in the study and beginning therapy.
Description

Non-hodgkins lymphoma of the cns

Data type

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C0280803
aged > 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy of at least 2 months
Description

Life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
adequate bone marrow reserve with a peripheral granulocyte count of > 1,500/µl and thrombocyte count of > 100,000/µl; bilirubin in the normal range; got of < three times the upper normal limit and adequate renal function with a creatinine clearance of > 50 ml/min and serum creatinine in the normal range.
Description

Bone marrow function, liver function and renal function

Data type

boolean

Alias
UMLS CUI [1]
C0857490
UMLS CUI [2]
C0005821
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0373595
UMLS CUI [6]
C0201976
written informed consent
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
in women of child-bearing age, pregnancy is excluded, effective contraception is necessary, and women should not be breast feeding.
Description

Gynaecological status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
manifestation of lymphoma outside of the cns
Description

Site affected by lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0449642
severe diseases in other organs which would make performing intensive chemotherapy impossible; karnofsky index > 50% due to previous diseases other than pcnsl. karnofsky > 30 will be accepted only due to the pcnsl.
Description

Comorbidity and Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0392920
UMLS CUI [2]
C0206065
active infection
Description

Active infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
HIV positivity
Description

HIV positivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
previous treatment of pcnsl other than with corticosteroids, antiepileptics or diuretics
Description

Pcnsl Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0280803
UMLS CUI [1,2]
C0087111
previous radiotherapy of the brain
Description

Radiotherapy to brain

Data type

boolean

Alias
UMLS CUI [1]
C0948319
concomitant or previous malignant diseases in the last 5 years except for an adequately treated basal cell carcinoma or cervical carcinoma in situ
Description

Cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0007117
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C2216722
immunosuppression, concomitant immunosuppressive therapy, or organ transplantation
Description

Immunosuppression and organ transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0029216
UMLS CUI [2]
C0021079
ongoing chemotherapy for another disease
Description

Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
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Similar models

Eligibility Central Nervous System Lymphoma NCT00153530

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-hodgkins lymphoma of the cns
Item
histologically or cytologically/immunocytologically confirmed primary non-hodgkin's lymphoma of the cns. a central reference pathological report will be made on inclusion into the study (prof. dr. pietsch, reference center for brain tumors of the german society for neuropathology and neuroanatomy, institute of neuropathology of the bonn university hospital). histological diagnosis is usually performed by preferential stereotactic biopsy of suspicious lesions in the brain or spinal cord. the diagnosis from cerebrospinal fluid (csf) requires the detection of malignant lymphocytes according to cytological and immunocytological criteria. there should be no more than 2 weeks between establishing the diagnosis and inclusion in the study. the availability of the reference pathological report is not absolutely necessary for inclusion in the study and beginning therapy.
boolean
C0024305 (UMLS CUI [1,1])
C0280803 (UMLS CUI [1,2])
Age
Item
aged > 18 years
boolean
C0001779 (UMLS CUI [1])
Life expectancy
Item
life expectancy of at least 2 months
boolean
C0023671 (UMLS CUI [1])
Bone marrow function, liver function and renal function
Item
adequate bone marrow reserve with a peripheral granulocyte count of > 1,500/µl and thrombocyte count of > 100,000/µl; bilirubin in the normal range; got of < three times the upper normal limit and adequate renal function with a creatinine clearance of > 50 ml/min and serum creatinine in the normal range.
boolean
C0857490 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0373595 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Gynaecological status
Item
in women of child-bearing age, pregnancy is excluded, effective contraception is necessary, and women should not be breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Site affected by lymphoma
Item
manifestation of lymphoma outside of the cns
boolean
C0024299 (UMLS CUI [1,1])
C0449642 (UMLS CUI [1,2])
Comorbidity and Karnofsky Performance Status
Item
severe diseases in other organs which would make performing intensive chemotherapy impossible; karnofsky index > 50% due to previous diseases other than pcnsl. karnofsky > 30 will be accepted only due to the pcnsl.
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0206065 (UMLS CUI [2])
Active infection
Item
active infection
boolean
C0009450 (UMLS CUI [1])
HIV positivity
Item
HIV positivity
boolean
C0019699 (UMLS CUI [1])
Pcnsl Treatment
Item
previous treatment of pcnsl other than with corticosteroids, antiepileptics or diuretics
boolean
C0280803 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Radiotherapy to brain
Item
previous radiotherapy of the brain
boolean
C0948319 (UMLS CUI [1])
Cancer
Item
concomitant or previous malignant diseases in the last 5 years except for an adequately treated basal cell carcinoma or cervical carcinoma in situ
boolean
C0006826 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0007117 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C2216722 (UMLS CUI [2,3])
Immunosuppression and organ transplantation
Item
immunosuppression, concomitant immunosuppressive therapy, or organ transplantation
boolean
C0029216 (UMLS CUI [1])
C0021079 (UMLS CUI [2])
Chemotherapy
Item
ongoing chemotherapy for another disease
boolean
C0392920 (UMLS CUI [1])
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