ID

31995

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01898598

Nyckelord

Versioner (1)
  1. 2018-10-10 2018-10-10 -
Rättsinnehavare

Hoffmann-La Roche

Uppladdad den

10 oktober 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility Basal Cell Carcinoma NCT01898598

Engelsk

Eligibility Basal Cell Carcinoma NCT01898598

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Age

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Compliance and willingness for study site attendance

Datatyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with vismodegib
Beskrivning

Prior treatment with vismodegib

Datatyp

boolean

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

known hypersensitivity to any of the study drug excipients

Datatyp

boolean

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

Any metastatic basal cell carcinoma

Datatyp

boolean

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

Inoperable basal cell carcinoma or contraindication to surgery

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Recent, current or planned participation in another experimental drug study

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Basal Cell Carcinoma NCT01898598

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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