Eligibility Non-Hodgkin's Lymphoma NCT00842114

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 years-75 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
pathologically confirmed low grade, follicular b cell lymphoma (who classification follicular grades 1 and 2) , marginal zone lymphoma or lymphocytic lymphoma (excluding cll and mcl)
Beschreibung

Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0024299
flipi score ≥ 2
Beschreibung

Follicular Lymphoma International Prognostic Index

Datentyp

boolean

Alias
UMLS CUI [1]
C4040298
chemotherapy-naïve patients. previous radiation therapy is allowed, but should have been limited.
Beschreibung

Prior chemotherapy or radiation

Datentyp

boolean

Alias
UMLS CUI [1]
C0279134
UMLS CUI [2]
C1514457
adequate hepatic (bilirubin or alt/ast < 2,5 times unl) and renal function, except for those directly disease-related
Beschreibung

Liver and Kidney Function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
performance status grade 0 to 3
Beschreibung

Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C1518965
frozen biopsy material obtained at relapse or disease progression should be available for central pathology review and molecular biology studies
Beschreibung

Biopsy Material for Pathology and Molecular Biology Studies

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1292533
UMLS CUI [1,2]
C0030664
UMLS CUI [2,1]
C1292533
UMLS CUI [2,2]
C0026376
patient information and written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous evolutive malignancy within 5 years of study entry
Beschreibung

Prior Malignancy

Datentyp

boolean

Alias
UMLS CUI [1]
C2735088
prior chemotherapy treatment
Beschreibung

Prior Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1514457
clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months of study entry
Beschreibung

Cardiac Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
known positivity for hiv, vhb or vhc
Beschreibung

HIV, HBV, HCV

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0149709
UMLS CUI [3]
C1112419
pregnant or lactating women. women of childbearing potential, and all men, unwilling to take appropriate contraceptive measures during and for at least 12 months after cessation of therapy
Beschreibung

Gynaecological Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
any uncontrolled serious non malignant condition or infection which would likely compromise the study objectives
Beschreibung

Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
non controlled thyroid disfunction
Beschreibung

Thyroid dysfunction

Datentyp

boolean

Alias
UMLS CUI [1]
C0348024
severe autoimmune disease
Beschreibung

Autoimmune disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
patients with history of severe neuropsychiatric disease
Beschreibung

Neuropsychiatric disease

Datentyp

boolean

Alias
UMLS CUI [1]
C3203509

Ähnliche Modelle

Eligibility Non-Hodgkin's Lymphoma NCT00842114

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 years-75 years
boolean
C0001779 (UMLS CUI [1])
Lymphoma
Item
pathologically confirmed low grade, follicular b cell lymphoma (who classification follicular grades 1 and 2) , marginal zone lymphoma or lymphocytic lymphoma (excluding cll and mcl)
boolean
C0024299 (UMLS CUI [1])
Follicular Lymphoma International Prognostic Index
Item
flipi score ≥ 2
boolean
C4040298 (UMLS CUI [1])
Prior chemotherapy or radiation
Item
chemotherapy-naïve patients. previous radiation therapy is allowed, but should have been limited.
boolean
C0279134 (UMLS CUI [1])
C1514457 (UMLS CUI [2])
Liver and Kidney Function
Item
adequate hepatic (bilirubin or alt/ast < 2,5 times unl) and renal function, except for those directly disease-related
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Performance Status
Item
performance status grade 0 to 3
boolean
C1518965 (UMLS CUI [1])
Biopsy Material for Pathology and Molecular Biology Studies
Item
frozen biopsy material obtained at relapse or disease progression should be available for central pathology review and molecular biology studies
boolean
C1292533 (UMLS CUI [1,1])
C0030664 (UMLS CUI [1,2])
C1292533 (UMLS CUI [2,1])
C0026376 (UMLS CUI [2,2])
Informed Consent
Item
patient information and written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Malignancy
Item
previous evolutive malignancy within 5 years of study entry
boolean
C2735088 (UMLS CUI [1])
Prior Chemotherapy
Item
prior chemotherapy treatment
boolean
C1514457 (UMLS CUI [1])
Cardiac Disease
Item
clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months of study entry
boolean
C0018799 (UMLS CUI [1])
HIV, HBV, HCV
Item
known positivity for hiv, vhb or vhc
boolean
C0019699 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Gynaecological Status
Item
pregnant or lactating women. women of childbearing potential, and all men, unwilling to take appropriate contraceptive measures during and for at least 12 months after cessation of therapy
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Comorbidity
Item
any uncontrolled serious non malignant condition or infection which would likely compromise the study objectives
boolean
C0009488 (UMLS CUI [1])
Thyroid dysfunction
Item
non controlled thyroid disfunction
boolean
C0348024 (UMLS CUI [1])
Autoimmune disease
Item
severe autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Neuropsychiatric disease
Item
patients with history of severe neuropsychiatric disease
boolean
C3203509 (UMLS CUI [1])