ID

22340

Beskrivning

Pilot Study of Imatinib (Gleevec) as Treatment for Advanced Thymic Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00314873

Länk

https://clinicaltrials.gov/show/NCT00314873

Nyckelord

Versioner (1)
  1. 2017-05-30 2017-05-30 -
Uppladdad den

30 maj 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Thymic Carcinoma NCT00314873

Engelsk

Eligibility Thymic Carcinoma NCT00314873

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological or cytological proof of advanced c-kit positive or pdgfr positive thymic carcinoma. for protocol purposes, advanced disease is defined as disease
Beskrivning

c-kit and pdgfr positive thymic carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205969
UMLS CUI [1,2]
C0072470
UMLS CUI [1,3]
C0071253
patient must have at least one documented measurable lesion obtained by imaging within 28 days prior to being registered for protocol therapy.
Beskrivning

measuable thymic carcinoma lesion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205969
UMLS CUI [1,2]
C1513041
no prior imatinib therapy.
Beskrivning

imatinib

Datatyp

boolean

Alias
UMLS CUI [1]
C0935989
age > 18 years at the time of consent
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of 0 or 1
Beskrivning

ecog

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
anc ≥ 1500/mm3,platelet count ≥ 100,000/mm,total bilirubin < 1.5uln,3.10 serum creatinine ≤ 1.7 mg/dl,alt and ast ≤ 3 x uln
Beskrivning

anc, platelet count, total bilirubin, serum creatinine, alt, ast

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0005821
UMLS CUI [3]
C0201913
UMLS CUI [4]
C0201976
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201899
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically significant infections as judged by the treating investigator
Beskrivning

infections

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
clinically significant concurrent illnesses
Beskrivning

comorbidity

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
females of childbearing potential not using birth control or breastfeeding
Beskrivning

females of childbearing potential birth control, breastfeeding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1960468
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0006147
prior radiation therapy > 25% of the bone marrow
Beskrivning

bone marrow radiation therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0005953
symptomatic brain metastasis
Beskrivning

symptomatic brain metastasis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
history of grade iii/iv cardiac problems
Beskrivning

cardiac problems

Datatyp

boolean

Alias
UMLS CUI [1]
C0262402
history of major surgery within 14 days prior to being registered
Beskrivning

major surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
treatment with any investigational agent within 30 days prior to being registered for protocol therapy.
Beskrivning

investigational agent

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Thymic Carcinoma NCT00314873

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
c-kit and pdgfr positive thymic carcinoma
Item
histological or cytological proof of advanced c-kit positive or pdgfr positive thymic carcinoma. for protocol purposes, advanced disease is defined as disease
boolean
C0205969 (UMLS CUI [1,1])
C0072470 (UMLS CUI [1,2])
C0071253 (UMLS CUI [1,3])
measuable thymic carcinoma lesion
Item
patient must have at least one documented measurable lesion obtained by imaging within 28 days prior to being registered for protocol therapy.
boolean
C0205969 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
imatinib
Item
no prior imatinib therapy.
boolean
C0935989 (UMLS CUI [1])
age
Item
age > 18 years at the time of consent
boolean
C0001779 (UMLS CUI [1])
ecog
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
anc, platelet count, total bilirubin, serum creatinine, alt, ast
Item
anc ≥ 1500/mm3,platelet count ≥ 100,000/mm,total bilirubin < 1.5uln,3.10 serum creatinine ≤ 1.7 mg/dl,alt and ast ≤ 3 x uln
boolean
C0948762 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0201913 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
infections
Item
clinically significant infections as judged by the treating investigator
boolean
C0009450 (UMLS CUI [1])
comorbidity
Item
clinically significant concurrent illnesses
boolean
C0009488 (UMLS CUI [1])
females of childbearing potential birth control, breastfeeding
Item
females of childbearing potential not using birth control or breastfeeding
boolean
C1960468 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
bone marrow radiation therapy
Item
prior radiation therapy > 25% of the bone marrow
boolean
C1522449 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
symptomatic brain metastasis
Item
symptomatic brain metastasis
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
cardiac problems
Item
history of grade iii/iv cardiac problems
boolean
C0262402 (UMLS CUI [1])
major surgery
Item
history of major surgery within 14 days prior to being registered
boolean
C0679637 (UMLS CUI [1])
investigational agent
Item
treatment with any investigational agent within 30 days prior to being registered for protocol therapy.
boolean
C0013230 (UMLS CUI [1])
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