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An Observational Study of Treatment Patterns and Effectiveness and Safety Outcomes in Advanced Basal Cell Carcinoma and Basal Cell Carcinoma Nevus Syndrome Patients(RegiSONIC)
Not Recruiting
Trial ID: NCT01604252
Purpose
This multi-center, prospective, observational cohort study will evaluate the effectiveness,
safety and utilization of treatments in patients with advanced basal cell carcinoma and basal
cell carcinoma nevus syndrome. The total study duration is anticipated to be a maximum of 8
years, including 3 years for patient recruitment and 5 years follow-up.
Official Title
A Prospective Observational Study of Treatment Patterns and Effectiveness and Safety Outcomes in Advanced Basal Cell Carcinoma and Basal Cell Carcinoma Nevus Syndrome Patients
Stanford Investigator(s)
Anne Lynn S. Chang, MD
Professor of Dermatology
Eligibility
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Patients with basal cell carcinoma (BCC) who meet either of the following definitions:
- Patients who were determined with advanced disease (aBCC) within 90 days prior to
study enrollment, have not been diagnosed with basal cell carcinoma nevus
syndrome (BCCNS) and have not been treated with an investigational or approved
hedgehog pathway inhibitor
- Patients with aBCC who have not been diagnosed with BCCNS and who were previously
treated with vismodegib as part of Genentech study SHH4476g, SHH4437g, or
SHH4811g (EAP)
- Patients with BCCNS who either have aBCC or multiple BCCs of any stage as defined
by protocol (may include patients previously enrolled in Genentech study
SHH4476g, SHH4437g, or SHH4811g (EAP))
Exclusion Criteria:
- Participation in a clinical trial within 90 days prior to study enrollment that has
either involved treatment of aBCC or involved treatment with an investigational or
approved hedgehog pathway inhibitor, except for patients treated with vismodegib as
part of Genentech study SHH4476g, SHH4437g, or SHH4811g (EAP)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061