0 Ratings
ID

31995

Description

A Study of Vismodegib With Surgery in Patients With Previously Untreated Basal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01898598 Sponsor: Hoffmann-La Roche Information provided by (Responsible Party): Hoffmann-La Roche Study Director: Clinical Trials Hoffmann-La Roche

Link

https://clinicaltrials.gov/show/NCT01898598

Keywords

Versions (1)
  1. 10/10/18 10/10/18 -
Copyright Holder

Hoffmann-La Roche

Uploaded on

October 10, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Eligibility Basal Cell Carcinoma NCT01898598

    English

    Eligibility Basal Cell Carcinoma NCT01898598

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    adult patients, >=18 years of age
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    diagnosis of non-infected, not recurrent, previously untreated basal cell carcinoma
    Description

    Diagnosis of non-infected, not recurrent, previously untreated basal cell carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007117
    UMLS CUI [1,2]
    C0521118
    UMLS CUI [2,1]
    C0007117
    UMLS CUI [2,2]
    C2945760
    UMLS CUI [2,3]
    C0332197
    UMLS CUI [3,1]
    C0007117
    UMLS CUI [3,2]
    C0332155
    free of any significant physical abnormalities (e.g., tattoos) at the target basal cell carcinoma site
    Description

    No significant physical abnormalities at the target basal cell carcinoma (e.g. tattoos)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007117
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0449695
    UMLS CUI [1,4]
    C0332197
    willing and able to participate in the study as an outpatient and agreement to make frequent visits to the clinic during the treatment and follow-up periods and to comply with study requirements
    Description

    Compliance and willingness for study site attendance

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    UMLS CUI [2,1]
    C0600109
    UMLS CUI [2,2]
    C2825164
    UMLS CUI [2,3]
    C2827364
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    prior treatment with vismodegib
    Description

    Prior treatment with vismodegib

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2987716
    UMLS CUI [1,2]
    C1514463
    known hypersensitivity to any of the study drug excipients
    Description

    known hypersensitivity to any of the study drug excipients

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C0015237
    any metastatic basal cell carcinoma
    Description

    Any metastatic basal cell carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1304306
    any locally advanced basal cell carcinoma considered to be inoperable or to have a medical contraindication to surgery
    Description

    Inoperable basal cell carcinoma or contraindication to surgery

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007117
    UMLS CUI [1,2]
    C0205187
    UMLS CUI [2]
    C0852649
    evidence of clinically significant and unstable diseases or conditions (e.g., cardiovascular, immunosuppressive, hematologic)
    Description

    Clinically significant and unstable diseases or conditions (e.g. cardiovascular, immunosuppressive, hematologic)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0443343
    UMLS CUI [1,3]
    C0750502
    UMLS CUI [2,1]
    C0007222
    UMLS CUI [2,2]
    C0443343
    UMLS CUI [2,3]
    C0750502
    UMLS CUI [3,1]
    C4048329
    UMLS CUI [3,2]
    C0009488
    UMLS CUI [3,3]
    C0443343
    UMLS CUI [3,4]
    C0750502
    UMLS CUI [4,1]
    C0018939
    UMLS CUI [4,2]
    C0443343
    UMLS CUI [4,3]
    C0750502
    any dermatological disease at the target basal cell carcinoma site that may cause difficulty with examination
    Description

    Any dermatological disease at the target basal cell carcinoma site that may cause difficulty with examination

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0037274
    UMLS CUI [1,3]
    C0449695
    recent, current, or planned participation in another experimental drug study
    Description

    Recent, current or planned participation in another experimental drug study

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
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    Similar models

    Eligibility Basal Cell Carcinoma NCT01898598

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    adult patients, >=18 years of age
    boolean
    C0001779 (UMLS CUI [1])
    Diagnosis of non-infected, not recurrent, previously untreated basal cell carcinoma
    Item
    diagnosis of non-infected, not recurrent, previously untreated basal cell carcinoma
    boolean
    C0007117 (UMLS CUI [1,1])
    C0521118 (UMLS CUI [1,2])
    C0007117 (UMLS CUI [2,1])
    C2945760 (UMLS CUI [2,2])
    C0332197 (UMLS CUI [2,3])
    C0007117 (UMLS CUI [3,1])
    C0332155 (UMLS CUI [3,2])
    No significant physical abnormalities at the target basal cell carcinoma (e.g. tattoos)
    Item
    free of any significant physical abnormalities (e.g., tattoos) at the target basal cell carcinoma site
    boolean
    C0007117 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0449695 (UMLS CUI [1,3])
    C0332197 (UMLS CUI [1,4])
    Compliance and willingness for study site attendance
    Item
    willing and able to participate in the study as an outpatient and agreement to make frequent visits to the clinic during the treatment and follow-up periods and to comply with study requirements
    boolean
    C1321605 (UMLS CUI [1])
    C0600109 (UMLS CUI [2,1])
    C2825164 (UMLS CUI [2,2])
    C2827364 (UMLS CUI [2,3])
    Item Group
    C0680251 (UMLS CUI)
    Prior treatment with vismodegib
    Item
    prior treatment with vismodegib
    boolean
    C2987716 (UMLS CUI [1,1])
    C1514463 (UMLS CUI [1,2])
    known hypersensitivity to any of the study drug excipients
    Item
    known hypersensitivity to any of the study drug excipients
    boolean
    C0020517 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0015237 (UMLS CUI [1,3])
    Any metastatic basal cell carcinoma
    Item
    any metastatic basal cell carcinoma
    boolean
    C1304306 (UMLS CUI [1])
    Inoperable basal cell carcinoma or contraindication to surgery
    Item
    any locally advanced basal cell carcinoma considered to be inoperable or to have a medical contraindication to surgery
    boolean
    C0007117 (UMLS CUI [1,1])
    C0205187 (UMLS CUI [1,2])
    C0852649 (UMLS CUI [2])
    Clinically significant and unstable diseases or conditions (e.g. cardiovascular, immunosuppressive, hematologic)
    Item
    evidence of clinically significant and unstable diseases or conditions (e.g., cardiovascular, immunosuppressive, hematologic)
    boolean
    C0009488 (UMLS CUI [1,1])
    C0443343 (UMLS CUI [1,2])
    C0750502 (UMLS CUI [1,3])
    C0007222 (UMLS CUI [2,1])
    C0443343 (UMLS CUI [2,2])
    C0750502 (UMLS CUI [2,3])
    C4048329 (UMLS CUI [3,1])
    C0009488 (UMLS CUI [3,2])
    C0443343 (UMLS CUI [3,3])
    C0750502 (UMLS CUI [3,4])
    C0018939 (UMLS CUI [4,1])
    C0443343 (UMLS CUI [4,2])
    C0750502 (UMLS CUI [4,3])
    Any dermatological disease at the target basal cell carcinoma site that may cause difficulty with examination
    Item
    any dermatological disease at the target basal cell carcinoma site that may cause difficulty with examination
    boolean
    C0009488 (UMLS CUI [1,1])
    C0037274 (UMLS CUI [1,2])
    C0449695 (UMLS CUI [1,3])
    Recent, current or planned participation in another experimental drug study
    Item
    recent, current, or planned participation in another experimental drug study
    boolean
    C2348568 (UMLS CUI [1])
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