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ID

22340

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00314873

Stichworte

  1. 30.05.17 30.05.17 -
Hochgeladen am

30. Mai 2017

DOI

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Lizenz

Creative Commons BY 4.0

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    Eligibility Thymic Carcinoma NCT00314873

    Eligibility Thymic Carcinoma NCT00314873

    Inclusion Criteria
    Beschreibung

    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
    Beschreibung

    c-kit and pdgfr positive thymic carcinoma

    Datentyp

    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.
    Beschreibung

    measuable thymic carcinoma lesion

    Datentyp

    boolean

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

    imatinib

    Datentyp

    boolean

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

    age

    Datentyp

    boolean

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

    ecog

    Datentyp

    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
    Beschreibung

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

    Datentyp

    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
    Beschreibung

    Exclusion Criteria

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

    infections

    Datentyp

    boolean

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

    comorbidity

    Datentyp

    boolean

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

    females of childbearing potential birth control, breastfeeding

    Datentyp

    boolean

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

    bone marrow radiation therapy

    Datentyp

    boolean

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

    symptomatic brain metastasis

    Datentyp

    boolean

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

    cardiac problems

    Datentyp

    boolean

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

    major surgery

    Datentyp

    boolean

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

    investigational agent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0013230

    Ähnliche Modelle

    Eligibility Thymic Carcinoma NCT00314873

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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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