ID

31995

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT01898598

Keywords

versioni (1)
  1. 10/10/18 10/10/18 -
Titolare del copyright

Hoffmann-La Roche

Caricato su

10 ottobre 2018

DOI

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Licenza

Creative Commons BY-NC 3.0
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Eligibility Basal Cell Carcinoma NCT01898598

Inglese

Eligibility Basal Cell Carcinoma NCT01898598

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

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

Age

Tipo di dati

boolean

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

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

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Descrizione

Compliance and willingness for study site attendance

Tipo di dati

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with vismodegib
Descrizione

Prior treatment with vismodegib

Tipo di dati

boolean

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

known hypersensitivity to any of the study drug excipients

Tipo di dati

boolean

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

Any metastatic basal cell carcinoma

Tipo di dati

boolean

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

Inoperable basal cell carcinoma or contraindication to surgery

Tipo di dati

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)
Descrizione

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

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Descrizione

Recent, current or planned participation in another experimental drug study

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Basal Cell Carcinoma NCT01898598

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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