An Observational Study of Treatment Patterns and Effectiveness and Safety Outcomes in Advanced Basal Cell Carcinoma and Basal Cell Carcinoma Nevus Syndrome Patients(RegiSONIC)
- Conditions
- Basal Cell Carcinoma
- Registration Number
- NCT01604252
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 503
-
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))
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of response approximately 5 years Safety: Incidence of adverse events approximately 5 years Recurrence rate approximately 5 years Progression-free survival approximately 5 years Response rate approximately 5 years Overall survival approximately 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (81)
Newport Dermatology and Laser Associates
🇺🇸Newport Beach, California, United States
Laser and Dermatologic Surgery Center
🇺🇸Chesterfield, Missouri, United States
Laser & Skin Surgery Center of Indiana
🇺🇸Carmel, Indiana, United States
University of Mississippi Medical Center; Division of Dermatology
🇺🇸Jackson, Mississippi, United States
Skin Cancer and Dermatology Institute
🇺🇸Reno, Nevada, United States
Dermatology Group, P.C.
🇺🇸Verona, New Jersey, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Long Island Skin Cancer and Dermatologic Surgery
🇺🇸Smithtown, New York, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Advanced Derm & Cosmetic Care
🇺🇸Valencia, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
California Pacific Medical Center Research Institute
🇺🇸Santa Rosa, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Clinical Research Specialists, Inc.
🇺🇸Santa Monica, California, United States
Mayo Clinic
🇺🇸Scottsdale, Arizona, United States
University of California Irvine
🇺🇸Irvine, California, United States
Moy-Fincher-Chipps Facial Plastics and Dermatology
🇺🇸Beverly Hills, California, United States
Scripps Clinic; Hematology & Oncology
🇺🇸La Jolla, California, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Skin and Cancer Associates and the Center for Cosmetic Enhancement
🇺🇸Plantation, Florida, United States
Mayo Clinic-Jacksonville
🇺🇸Jacksonville, Florida, United States
Pacific Dermatology Institute
🇺🇸Temecula, California, United States
Gwinnett Clinical Research Center
🇺🇸Snellville, Georgia, United States
MLF Knuckles, MD, PSC
🇺🇸Corbin, Kentucky, United States
Fairmont Dermatology Medical Associates, Inc.
🇺🇸Lodi, California, United States
Dermatology Research Associate
🇺🇸Los Angeles, California, United States
University of California San Diego
🇺🇸La Jolla, California, United States
Belleair Research Center
🇺🇸Pinellas Park, Florida, United States
Georgia Skin Cancer and Aesthetic Dermatology
🇺🇸Athens, Georgia, United States
Faulkner Hospital
🇺🇸Jamaica Plain, Massachusetts, United States
Emory Univ Winship Cancer Inst
🇺🇸Atlanta, Georgia, United States
Dermatologic Surgery Specialists, Inc
🇺🇸Macon, Georgia, United States
Northwest Georgia Dermatology and Skin Cancer Specialists
🇺🇸Marietta, Georgia, United States
Southern IL Univ School of Med
🇺🇸Springfield, Illinois, United States
Florida Research Specialists
🇺🇸Seminole, Florida, United States
Hollywood Dermatology and Cosmetic Specialists
🇺🇸Hollywood, Florida, United States
Spencer Derma & Skin Surg Ctr
🇺🇸Saint Petersburg, Florida, United States
NOVA Southeastern University
🇺🇸Fort Lauderdale, Florida, United States
Alma M Cruz MD
🇵🇷Carolina, Puerto Rico
Dermatology Associates and Research
🇺🇸Coral Gables, Florida, United States
Advanced Derm & Cosmetic Surg
🇺🇸Ormond Beach, Florida, United States
Kenneth R. Beer, M.D., PA
🇺🇸West Palm Beach, Florida, United States
Saint Louis University School of Medicine; Department of Dermatology
🇺🇸Saint Louis, Missouri, United States
Shideler Clinical Research Center
🇺🇸Carmel, Indiana, United States
Indiana Clinical Trial Center
🇺🇸Plainfield, Indiana, United States
Beverly Hospital, A Member of Lahey Health
🇺🇸Beverly, Massachusetts, United States
Atlantic Health System
🇺🇸Morristown, New Jersey, United States
Bettencourt Skin Center
🇺🇸Henderson, Nevada, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Manish J. Gharia, MD
🇺🇸Brookfield, Wisconsin, United States
Dermatology Associates PLLC
🇺🇸Seattle, Washington, United States
Associated Dermatology and Skin Cancer Clinic of Helena, PC
🇺🇸Helena, Montana, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
University of Rochester
🇺🇸Rochester, New York, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
South Texas Research Alliance LLC
🇺🇸Laredo, Texas, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
South Valley Dermatology Center
🇺🇸West Jordan, Utah, United States
Ohio State University; Comp Can Ctr
🇺🇸Columbus, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Huntington Internal Medicine Group
🇺🇸Huntington, West Virginia, United States
Skin Surgery Med Group, Inc
🇺🇸San Diego, California, United States
University Clinical Trials
🇺🇸San Diego, California, United States
University of Miami
🇺🇸Miami, Florida, United States
University of Minnesota.
🇺🇸Minneapolis, Minnesota, United States
Linda Woodson Dermatology, A Professional Corporation
🇺🇸Las Vegas, Nevada, United States
Woodson Dermatology
🇺🇸Las Vegas, Nevada, United States
Strimling Dermatology, Laser and Vein Institute
🇺🇸Las Vegas, Nevada, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Oklahoma Health Sciences Cente; Department of Dermatology
🇺🇸Oklahoma City, Oklahoma, United States
The Sarah Cannon Research Inst
🇺🇸Nashville, Tennessee, United States
DermSurgery Associates, PA
🇺🇸Houston, Texas, United States
University of Colorado; Anschutz Cancer Pavilion
🇺🇸Aurora, Colorado, United States
Derm Research, LLC
🇺🇸Louisville, Kentucky, United States
Dermatology and Laser Center of Charleston PA
🇺🇸Charleston, South Carolina, United States
H. Lee Moffitt Cancer Center and Research Inst.
🇺🇸Tampa, Florida, United States
University of North Carolina At Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
University of South Florida
🇺🇸Tampa, Florida, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
The Skin Surgery Center
🇺🇸Winston-Salem, North Carolina, United States