ID

21762

Beschrijving

Intensive Chemo-immunotherapy as First Line Treatment in Adult Patients With Peripheral T- Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01679860

Link

https://clinicaltrials.gov/show/NCT01679860

Trefwoorden

Versies (1)
  1. 28-04-17 28-04-17 -
Geüploaded op

28 april 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Lymphoma, T-Cell, Peripheral NCT01679860

Engels

Eligibility Lymphoma, T-Cell, Peripheral NCT01679860

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥18 <60 years (patients older than 60 years are excluded because of the intensive chemotherapy and transplant procedures)
Beschrijving

Age | Chemotherapy intense | Transplantation

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0522510
UMLS CUI [3]
C0040732
histologically proven diagnosis of ptcl, including the following categories: ptcl-u (peripheral t-cell lymphoma, unspecified), aild-t (angioimmunoblastic-like t-cell lymphoma), alkneg alcl (alk-negative anaplastic large cell lymphoma),intestinal t -
Beschrijving

Peripheral T-Cell Lymphoma | Angioimmunoblastic T-cell lymphoma | Anaplastic large cell lymphoma, ALK negative | Intestinal T-Cell Lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0079774
UMLS CUI [2]
C0020981
UMLS CUI [3]
C1332078
UMLS CUI [4]
C0456889
advanced stage disease (stage ii-iv) or stage i and aaipi score ≥ 2
Beschrijving

advanced disease Ann Arbor lymphoma staging system

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679246
UMLS CUI [1,2]
C0432516
written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
histological ptcl subset other than ptcl-u, aild-t alcl-alkneg, intestinal t - nhl
Beschrijving

Peripheral T-Cell Lymphoma Other

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079774
UMLS CUI [1,2]
C0205394
central nervous system localization
Beschrijving

Central Nervous System localization

Datatype

boolean

Alias
UMLS CUI [1,1]
C3714787
UMLS CUI [1,2]
C0475264
positive serologic markers for human immunodeficiency virus (hiv), hepatitis b virus (hbv), and hepatitis c virus (hcv) infection
Beschrijving

HIV Seropositivity | Hepatitis B | Hepatitis C

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
serum bilirubin levels > 2 the upper normal limit
Beschrijving

Serum bilirubin increased

Datatype

boolean

Alias
UMLS CUI [1]
C0859062
clearance of creatinine < 50 ml/min
Beschrijving

Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0373595
dlco < 50%
Beschrijving

Carbon Monoxide Diffusing Capability Test

Datatype

boolean

Alias
UMLS CUI [1]
C1516251
ejection fraction < 45% (or myocardial infarction in the last 12 months)
Beschrijving

Cardiac ejection fraction | Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0232174
UMLS CUI [2]
C0027051
pregnancy or lactation
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient not agreeing to take adequate contraceptive measures during the study
Beschrijving

Contraceptive methods Disagree

Datatype

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C3641828
psychiatric disease
Beschrijving

Mental disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0004936
any active, uncontrolled infection
Beschrijving

Communicable Disease Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
type i hypersensitivity or anaphylactic reactions to proteins drugs
Beschrijving

Hypersensitivity Protein drugs | Anaphylaxis Protein drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0033684
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0033684
UMLS CUI [2,3]
C0013227
active secondary malignancy
Beschrijving

Secondary Malignant Neoplasm

Datatype

boolean

Alias
UMLS CUI [1]
C3266877
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Similar models

Eligibility Lymphoma, T-Cell, Peripheral NCT01679860

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Chemotherapy intense | Transplantation
Item
age ≥18 <60 years (patients older than 60 years are excluded because of the intensive chemotherapy and transplant procedures)
boolean
C0001779 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C0040732 (UMLS CUI [3])
Peripheral T-Cell Lymphoma | Angioimmunoblastic T-cell lymphoma | Anaplastic large cell lymphoma, ALK negative | Intestinal T-Cell Lymphoma
Item
histologically proven diagnosis of ptcl, including the following categories: ptcl-u (peripheral t-cell lymphoma, unspecified), aild-t (angioimmunoblastic-like t-cell lymphoma), alkneg alcl (alk-negative anaplastic large cell lymphoma),intestinal t -
boolean
C0079774 (UMLS CUI [1])
C0020981 (UMLS CUI [2])
C1332078 (UMLS CUI [3])
C0456889 (UMLS CUI [4])
advanced disease Ann Arbor lymphoma staging system
Item
advanced stage disease (stage ii-iv) or stage i and aaipi score ≥ 2
boolean
C0679246 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Peripheral T-Cell Lymphoma Other
Item
histological ptcl subset other than ptcl-u, aild-t alcl-alkneg, intestinal t - nhl
boolean
C0079774 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Central Nervous System localization
Item
central nervous system localization
boolean
C3714787 (UMLS CUI [1,1])
C0475264 (UMLS CUI [1,2])
HIV Seropositivity | Hepatitis B | Hepatitis C
Item
positive serologic markers for human immunodeficiency virus (hiv), hepatitis b virus (hbv), and hepatitis c virus (hcv) infection
boolean
C0019699 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Serum bilirubin increased
Item
serum bilirubin levels > 2 the upper normal limit
boolean
C0859062 (UMLS CUI [1])
Creatinine clearance measurement
Item
clearance of creatinine < 50 ml/min
boolean
C0373595 (UMLS CUI [1])
Carbon Monoxide Diffusing Capability Test
Item
dlco < 50%
boolean
C1516251 (UMLS CUI [1])
Cardiac ejection fraction | Myocardial Infarction
Item
ejection fraction < 45% (or myocardial infarction in the last 12 months)
boolean
C0232174 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraceptive methods Disagree
Item
patient not agreeing to take adequate contraceptive measures during the study
boolean
C0700589 (UMLS CUI [1,1])
C3641828 (UMLS CUI [1,2])
Mental disorders
Item
psychiatric disease
boolean
C0004936 (UMLS CUI [1])
Communicable Disease Uncontrolled
Item
any active, uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Hypersensitivity Protein drugs | Anaphylaxis Protein drugs
Item
type i hypersensitivity or anaphylactic reactions to proteins drugs
boolean
C0020517 (UMLS CUI [1,1])
C0033684 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0002792 (UMLS CUI [2,1])
C0033684 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
Secondary Malignant Neoplasm
Item
active secondary malignancy
boolean
C3266877 (UMLS CUI [1])
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