An Observational Study of Treatment Patterns and Effectiveness and Safety Outcomes in Advanced Basal Cell Carcinoma and Basal Cell Carcinoma Nevus Syndrome Patients(RegiSONIC)

Stopped early

Conditions studied: Basal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT01604252

Run by

Genentech, Inc.

People needed

503

Starts

2012-06-20

Expected to finish

2017-04-28

Last updated by the study team

2017-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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))

You may not qualify if…

• 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)

Where it is running

• Arizona Cancer Center — Tucson, Arizona, United States
• Moy-Fincher-Chipps Facial Plastics and Dermatology — Beverly Hills, California, United States
• University of California Irvine — Irvine, California, United States
• Scripps Clinic; Hematology & Oncology — La Jolla, California, United States
• University of California San Diego — La Jolla, California, United States
• Fairmont Dermatology Medical Associates, Inc. — Lodi, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Dermatology Research Associate — Los Angeles, California, United States
• Newport Dermatology and Laser Associates — Newport Beach, California, United States
• Stanford University — Palo Alto, California, United States
• Skin Surgery Med Group, Inc — San Diego, California, United States
• University Clinical Trials — San Diego, California, United States
• Clinical Research Specialists, Inc. — Santa Monica, California, United States
• California Pacific Medical Center Research Institute — Santa Rosa, California, United States
• Pacific Dermatology Institute — Temecula, California, United States
• Advanced Derm & Cosmetic Care — Valencia, California, United States
• University of Colorado; Anschutz Cancer Pavilion — Aurora, Colorado, United States
• Dermatology Associates and Research — Coral Gables, Florida, United States
• NOVA Southeastern University — Fort Lauderdale, Florida, United States
• Hollywood Dermatology and Cosmetic Specialists — Hollywood, Florida, United States
• Mayo Clinic-Jacksonville — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Advanced Derm & Cosmetic Surg — Ormond Beach, Florida, United States
• Belleair Research Center — Pinellas Park, Florida, United States
• Mayo Clinic — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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