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ID

22340

Beschrijving

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

Trefwoorden

Versies (1)
  1. 5/30/17 5/30/17 -
Geüploaded op

May 30, 2017

DOI

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Creative Commons BY 4.0
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    Eligibility Thymic Carcinoma NCT00314873

    Engels

    Eligibility Thymic Carcinoma NCT00314873

    1 Formulieren  
    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

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

    c-kit and pdgfr positive thymic carcinoma

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0205969 (Thymic Carcinoma)
    SNOMED
    444374006
    UMLS CUI [1,2]
    C0072470 (Proto-Oncogene Protein c-kit)
    SNOMED
    103165007
    LOINC
    LP20052-4
    UMLS CUI [1,3]
    C0071253 (Platelet-Derived Growth Factor Receptor)
    patient must have at least one documented measurable lesion obtained by imaging within 28 days prior to being registered for protocol therapy.
    Beschrijving

    measuable thymic carcinoma lesion

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0205969 (Thymic Carcinoma)
    SNOMED
    444374006
    UMLS CUI [1,2]
    C1513041 (Measurable Disease)
    no prior imatinib therapy.
    Beschrijving

    imatinib

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0935989 (imatinib)
    SNOMED
    391634008
    age > 18 years at the time of consent
    Beschrijving

    age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    ecog performance status of 0 or 1
    Beschrijving

    ecog

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    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
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0948762 (Absolute neutrophil count)
    UMLS CUI [2]
    C0005821 (Blood Platelets)
    SNOMED
    16378004
    LOINC
    LP70360-0
    UMLS CUI [3]
    C0201913 (Bilirubin, total measurement)
    SNOMED
    359986008
    UMLS CUI [4]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    UMLS CUI [5]
    C0201836 (Alanine aminotransferase measurement)
    SNOMED
    34608000
    UMLS CUI [6]
    C0201899 (Aspartate aminotransferase measurement)
    SNOMED
    45896001
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    clinically significant infections as judged by the treating investigator
    Beschrijving

    infections

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    clinically significant concurrent illnesses
    Beschrijving

    comorbidity

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0009488 (Comorbidity)
    females of childbearing potential not using birth control or breastfeeding
    Beschrijving

    females of childbearing potential birth control, breastfeeding

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1960468 (Female of child bearing age)
    SNOMED
    427504007
    UMLS CUI [1,2]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    prior radiation therapy > 25% of the bone marrow
    Beschrijving

    bone marrow radiation therapy

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    UMLS CUI [1,2]
    C0005953 (Bone Marrow)
    SNOMED
    279729006
    LOINC
    LP7410-6
    symptomatic brain metastasis
    Beschrijving

    symptomatic brain metastasis

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0220650 (Metastatic malignant neoplasm to brain)
    SNOMED
    94225005
    UMLS CUI [1,2]
    C0231220 (Symptomatic)
    SNOMED
    264931009
    LOINC
    LA17766-9
    history of grade iii/iv cardiac problems
    Beschrijving

    cardiac problems

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0262402 (cardiac problem)
    history of major surgery within 14 days prior to being registered
    Beschrijving

    major surgery

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0679637 (major surgery)
    treatment with any investigational agent within 30 days prior to being registered for protocol therapy.
    Beschrijving

    investigational agent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0013230 (Investigational New Drugs)
    Terug naar het begin van de pagina

    Similar models

    Eligibility Thymic Carcinoma NCT00314873

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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])
    Terug naar het begin van de pagina 

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