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

NCT01604252 | Terminated

• 1 other identifier: ML28296
• Study Type: observational
• Target: 503
• Locations: 2 countries
• Sites: 81

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.

Conditions

Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (6)

• Response rate

  approximately 5 years

• Duration of response

  approximately 5 years

• Recurrence rate

  approximately 5 years

• Progression-free survival

  approximately 5 years

• Overall survival

  approximately 5 years

• Safety: Incidence of adverse events

  approximately 5 years

Study Arms (1)

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients treated for advanced basal cell carcinoma and basal cell carcinoma nevus syndrome

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)

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (81)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Moy-Fincher-Chipps Facial Plastics and Dermatology

Beverly Hills, California, 90210, United States

Location

University of California Irvine

Irvine, California, 92697, United States

Location

Scripps Clinic; Hematology & Oncology

La Jolla, California, 92037-1027, United States

Location

University of California San Diego

La Jolla, California, 92093, United States

Location

Fairmont Dermatology Medical Associates, Inc.

Lodi, California, 95242, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Dermatology Research Associate

Los Angeles, California, 90045, United States

Location

Newport Dermatology and Laser Associates

Newport Beach, California, 92660, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Skin Surgery Med Group, Inc

San Diego, California, 92117, United States

Location

University Clinical Trials

San Diego, California, 92123, United States

Location

Clinical Research Specialists, Inc.

Santa Monica, California, 90404-2115, United States

Location

California Pacific Medical Center Research Institute

Santa Rosa, California, 95403, United States

Location

Pacific Dermatology Institute

Temecula, California, 92592, United States

Location

Advanced Derm & Cosmetic Care

Valencia, California, 91355, United States

Location

University of Colorado; Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

Dermatology Associates and Research

Coral Gables, Florida, 33134, United States

Location

NOVA Southeastern University

Fort Lauderdale, Florida, 33328, United States

Location

Hollywood Dermatology and Cosmetic Specialists

Hollywood, Florida, 33021, United States

Location

Mayo Clinic-Jacksonville

Jacksonville, Florida, 32224, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Advanced Derm & Cosmetic Surg

Ormond Beach, Florida, 32174, United States

Location

Belleair Research Center

Pinellas Park, Florida, 33781, United States

Location

Skin and Cancer Associates and the Center for Cosmetic Enhancement

Plantation, Florida, 33324, United States

Location

Florida Research Specialists

Seminole, Florida, 33708, United States

Location

Spencer Derma & Skin Surg Ctr

St. Petersburg, Florida, 33716, United States

Location

H. Lee Moffitt Cancer Center and Research Inst.

Tampa, Florida, 33612, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Kenneth R. Beer, M.D., PA

West Palm Beach, Florida, 33401, United States

Location

Georgia Skin Cancer and Aesthetic Dermatology

Athens, Georgia, 30606, United States

Location

Emory Univ Winship Cancer Inst

Atlanta, Georgia, 30322, United States

Location

Dermatologic Surgery Specialists, Inc

Macon, Georgia, 31217, United States

Location

Northwest Georgia Dermatology and Skin Cancer Specialists

Marietta, Georgia, 30060, United States

Location

Gwinnett Clinical Research Center

Snellville, Georgia, 30078, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Southern IL Univ School of Med

Springfield, Illinois, 62702, United States

Location

Laser & Skin Surgery Center of Indiana

Carmel, Indiana, 46032, United States

Location

Shideler Clinical Research Center

Carmel, Indiana, 46032, United States

Location

Indiana Clinical Trial Center

Plainfield, Indiana, 46168, United States

Location

MLF Knuckles, MD, PSC

Corbin, Kentucky, 40701, United States

Location

Derm Research, LLC

Louisville, Kentucky, 40217, United States

Location

Beverly Hospital, A Member of Lahey Health

Beverly, Massachusetts, 01915, United States

Location

Faulkner Hospital

Jamaica Plain, Massachusetts, 02130, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota.

Minneapolis, Minnesota, 55454, United States

Location

University of Mississippi Medical Center; Division of Dermatology

Jackson, Mississippi, 39216, United States

Location

Laser and Dermatologic Surgery Center

Chesterfield, Missouri, 63017, United States

Location

Saint Louis University School of Medicine; Department of Dermatology

St Louis, Missouri, 63104, United States

Location

Associated Dermatology and Skin Cancer Clinic of Helena, PC

Helena, Montana, 59601, United States

Location

Bettencourt Skin Center

Henderson, Nevada, 89074, United States

Location

Linda Woodson Dermatology, A Professional Corporation

Las Vegas, Nevada, 89128, United States

Location

Woodson Dermatology

Las Vegas, Nevada, 89128, United States

Location

Strimling Dermatology, Laser and Vein Institute

Las Vegas, Nevada, 89144, United States

Location

Skin Cancer and Dermatology Institute

Reno, Nevada, 89509, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Atlantic Health System

Morristown, New Jersey, 07960, United States

Location

Dermatology Group, P.C.

Verona, New Jersey, 07044, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Location

University of Rochester

Rochester, New York, 14623, United States

Location

Long Island Skin Cancer and Dermatologic Surgery

Smithtown, New York, 11787, United States

Location

University of North Carolina At Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

The Skin Surgery Center

Winston-Salem, North Carolina, 27106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University; Comp Can Ctr

Columbus, Ohio, 43210, United States

Location

University of Oklahoma Health Sciences Cente; Department of Dermatology

Oklahoma City, Oklahoma, 73104, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Dermatology and Laser Center of Charleston PA

Charleston, South Carolina, 29414, United States

Location

The Sarah Cannon Research Inst

Nashville, Tennessee, 37203, United States

Location

DermSurgery Associates, PA

Houston, Texas, 77030, United States

Location

South Texas Research Alliance LLC

Laredo, Texas, 78041, United States

Location

South Valley Dermatology Center

West Jordan, Utah, 84088, United States

Location

Dermatology Associates PLLC

Seattle, Washington, 98101, United States

Location

Huntington Internal Medicine Group

Huntington, West Virginia, 25705, United States

Location

Manish J. Gharia, MD

Brookfield, Wisconsin, 53045, United States

Location

Alma M Cruz MD

Carolina, 00985, Puerto Rico

Location

Biospecimen

Retention: SAMPLES WITH DNA

optional blood sample

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2012
• First Posted: May 23, 2012
• Study Start: June 20, 2012
• Primary Completion: April 28, 2017
• Study Completion: April 28, 2017
• Last Updated: July 28, 2017

Record last verified: 2017-06

Locations

PR (1); US (80)