ID

31764

Beschrijving

Carboplatin and Docetaxel Followed by Epstein-Barr Virus Cytotoxic T Lymphocytes; ODM derived from: https://clinicaltrials.gov/show/NCT00953420

Link

https://clinicaltrials.gov/show/NCT00953420

Trefwoorden

Versies (1)
  1. 26-09-18 26-09-18 -
Houder van rechten

Chrystal Louis, Baylor College of Medicine

Geüploaded op

26 september 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Eligibility Nasopharyngeal Carcinoma NCT00953420

Engels

Eligibility Nasopharyngeal Carcinoma NCT00953420

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
nasopharyngeal carcinoma in first or subsequent relapse or with primary refractory disease in whom the ebv-genome or antigens have been demonstrated in tissue biopsy samples
Beschrijving

Nasopharynx carcinoma relapse or refractory disease, EBV-genome or -anitgens

Datatype

boolean

Alias
UMLS CUI [1,1]
C2931822
UMLS CUI [1,2]
C0277556
UMLS CUI [2,1]
C2931822
UMLS CUI [2,2]
C1514815
UMLS CUI [3,1]
C0014644
UMLS CUI [3,2]
C0017428
UMLS CUI [3,3]
C0005558
UMLS CUI [4,1]
C0014644
UMLS CUI [4,2]
C0003320
UMLS CUI [4,3]
C0005558
age 10 years or older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy of 8 weeks or more
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
karnofsky or lansky score of 50 or more
Beschrijving

Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
normal bilirubin level (per institutional standard)
Beschrijving

Normal bilirubin

Datatype

boolean

Alias
UMLS CUI [1]
C0005437
ast and alt 1.5 x or less upper limit of normal
Beschrijving

AST and ALT upper limit of normal

Datatype

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
alk phos level less than 2.5 x upper limit of normal
Beschrijving

Alkaline phosphatase upper limit of normal

Datatype

boolean

Alias
UMLS CUI [1]
C0002059
anc greater than 1500 cells/ul
Beschrijving

ANC

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
hgb 8.0 or greater
Beschrijving

Hemoglobin

Datatype

boolean

Alias
UMLS CUI [1]
C0019046
platelets 100,000 cells/ul or more
Beschrijving

Platelets

Datatype

boolean

Alias
UMLS CUI [1]
C0005821
creatinine 2 x or less uln or gfr 50 ml/min/1.73 m2 or more
Beschrijving

Creatinin upper limit of normal, GFR

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0017654
women of child-bearing potential must take/use effective birth control while participating in the study.
Beschrijving

Female of child bearing age; Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C1960468
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
due to the unknown effects of this therapy on a fetus, pregnant women will be excluded from this research.
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
prior allergic reaction to the study drugs used in this protocol or other drugs formulated with polysorbate 80.
Beschrijving

Prior allergic to study drugs or other drugs formulated with polysorbate 80

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2603343
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0032601
known hiv positive subjects since treatment may be significantly immunosuppressive
Beschrijving

HIV positive

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
women who are breast-feeding
Beschrijving

Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
severe intercurrent infection or uncontrolled condition
Beschrijving

Communicable Diseases, uncontrolled medical condition

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0205318
UMLS CUI [2,2]
C0012634
patients, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Beschrijving

Ability complying safety monitoring requirements

Datatype

boolean

Alias
UMLS CUI [1,1]
C0036043
UMLS CUI [1,2]
C1516647
UMLS CUI [1,3]
C1321605
UMLS CUI [1,4]
C0439801
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Similar models

Eligibility Nasopharyngeal Carcinoma NCT00953420

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Nasopharynx carcinoma relapse or refractory disease, EBV-genome or -anitgens
Item
nasopharyngeal carcinoma in first or subsequent relapse or with primary refractory disease in whom the ebv-genome or antigens have been demonstrated in tissue biopsy samples
boolean
C2931822 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
C2931822 (UMLS CUI [2,1])
C1514815 (UMLS CUI [2,2])
C0014644 (UMLS CUI [3,1])
C0017428 (UMLS CUI [3,2])
C0005558 (UMLS CUI [3,3])
C0014644 (UMLS CUI [4,1])
C0003320 (UMLS CUI [4,2])
C0005558 (UMLS CUI [4,3])
Age
Item
age 10 years or older
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of 8 weeks or more
boolean
C0023671 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky or lansky score of 50 or more
boolean
C0206065 (UMLS CUI [1])
Normal bilirubin
Item
normal bilirubin level (per institutional standard)
boolean
C0005437 (UMLS CUI [1])
AST and ALT upper limit of normal
Item
ast and alt 1.5 x or less upper limit of normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Alkaline phosphatase upper limit of normal
Item
alk phos level less than 2.5 x upper limit of normal
boolean
C0002059 (UMLS CUI [1])
ANC
Item
anc greater than 1500 cells/ul
boolean
C0948762 (UMLS CUI [1])
Hemoglobin
Item
hgb 8.0 or greater
boolean
C0019046 (UMLS CUI [1])
Platelets
Item
platelets 100,000 cells/ul or more
boolean
C0005821 (UMLS CUI [1])
Creatinin upper limit of normal, GFR
Item
creatinine 2 x or less uln or gfr 50 ml/min/1.73 m2 or more
boolean
C0201976 (UMLS CUI [1])
C0017654 (UMLS CUI [2])
Female of child bearing age; Contraceptive methods
Item
women of child-bearing potential must take/use effective birth control while participating in the study.
boolean
C1960468 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
due to the unknown effects of this therapy on a fetus, pregnant women will be excluded from this research.
boolean
C0032961 (UMLS CUI [1])
Prior allergic to study drugs or other drugs formulated with polysorbate 80
Item
prior allergic reaction to the study drugs used in this protocol or other drugs formulated with polysorbate 80.
boolean
C0020517 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0032601 (UMLS CUI [2,3])
HIV positive
Item
known hiv positive subjects since treatment may be significantly immunosuppressive
boolean
C0019699 (UMLS CUI [1])
Breast Feeding
Item
women who are breast-feeding
boolean
C0006147 (UMLS CUI [1])
Communicable Diseases, uncontrolled medical condition
Item
severe intercurrent infection or uncontrolled condition
boolean
C0009450 (UMLS CUI [1])
C0205318 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
Ability complying safety monitoring requirements
Item
patients, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
boolean
C0036043 (UMLS CUI [1,1])
C1516647 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
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