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

NCT ID: NCT01604252

Last Updated: 2017-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

503 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-20

Study Completion Date

2017-04-28

Brief Summary

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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

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Conditions

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Basal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

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Mayo Clinic

Scottsdale, Arizona, United States

Site Status

Arizona Cancer Center

Tucson, Arizona, United States

Site Status

Moy-Fincher-Chipps Facial Plastics and Dermatology

Beverly Hills, California, United States

Site Status

University of California Irvine

Irvine, California, United States

Site Status

Scripps Clinic; Hematology & Oncology

La Jolla, California, United States

Site Status

University of California San Diego

La Jolla, California, United States

Site Status

Fairmont Dermatology Medical Associates, Inc.

Lodi, California, United States

Site Status

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

Dermatology Research Associate

Los Angeles, California, United States

Site Status

Newport Dermatology and Laser Associates

Newport Beach, California, United States

Site Status

Stanford University

Palo Alto, California, United States

Site Status

Skin Surgery Med Group, Inc

San Diego, California, United States

Site Status

University Clinical Trials

San Diego, California, United States

Site Status

Clinical Research Specialists, Inc.

Santa Monica, California, United States

Site Status

California Pacific Medical Center Research Institute

Santa Rosa, California, United States

Site Status

Pacific Dermatology Institute

Temecula, California, United States

Site Status

Advanced Derm & Cosmetic Care

Valencia, California, United States

Site Status

University of Colorado; Anschutz Cancer Pavilion

Aurora, Colorado, United States

Site Status

Dermatology Associates and Research

Coral Gables, Florida, United States

Site Status

NOVA Southeastern University

Fort Lauderdale, Florida, United States

Site Status

Hollywood Dermatology and Cosmetic Specialists

Hollywood, Florida, United States

Site Status

Mayo Clinic-Jacksonville

Jacksonville, Florida, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Advanced Derm & Cosmetic Surg

Ormond Beach, Florida, United States

Site Status

Belleair Research Center

Pinellas Park, Florida, United States

Site Status

Skin and Cancer Associates and the Center for Cosmetic Enhancement

Plantation, Florida, United States

Site Status

Florida Research Specialists

Seminole, Florida, United States

Site Status

Spencer Derma & Skin Surg Ctr

St. Petersburg, Florida, United States

Site Status

H. Lee Moffitt Cancer Center and Research Inst.

Tampa, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Kenneth R. Beer, M.D., PA

West Palm Beach, Florida, United States

Site Status

Georgia Skin Cancer and Aesthetic Dermatology

Athens, Georgia, United States

Site Status

Emory Univ Winship Cancer Inst

Atlanta, Georgia, United States

Site Status

Dermatologic Surgery Specialists, Inc

Macon, Georgia, United States

Site Status

Northwest Georgia Dermatology and Skin Cancer Specialists

Marietta, Georgia, United States

Site Status

Gwinnett Clinical Research Center

Snellville, Georgia, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Southern IL Univ School of Med

Springfield, Illinois, United States

Site Status

Laser & Skin Surgery Center of Indiana

Carmel, Indiana, United States

Site Status

Shideler Clinical Research Center

Carmel, Indiana, United States

Site Status

Indiana Clinical Trial Center

Plainfield, Indiana, United States

Site Status

MLF Knuckles, MD, PSC

Corbin, Kentucky, United States

Site Status

Derm Research, LLC

Louisville, Kentucky, United States

Site Status

Beverly Hospital, A Member of Lahey Health

Beverly, Massachusetts, United States

Site Status

Faulkner Hospital

Jamaica Plain, Massachusetts, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

University of Minnesota.

Minneapolis, Minnesota, United States

Site Status

University of Mississippi Medical Center; Division of Dermatology

Jackson, Mississippi, United States

Site Status

Laser and Dermatologic Surgery Center

Chesterfield, Missouri, United States

Site Status

Saint Louis University School of Medicine; Department of Dermatology

St Louis, Missouri, United States

Site Status

Associated Dermatology and Skin Cancer Clinic of Helena, PC

Helena, Montana, United States

Site Status

Bettencourt Skin Center

Henderson, Nevada, United States

Site Status

Linda Woodson Dermatology, A Professional Corporation

Las Vegas, Nevada, United States

Site Status

Woodson Dermatology

Las Vegas, Nevada, United States

Site Status

Strimling Dermatology, Laser and Vein Institute

Las Vegas, Nevada, United States

Site Status

Skin Cancer and Dermatology Institute

Reno, Nevada, United States

Site Status

Cooper University Hospital

Camden, New Jersey, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Atlantic Health System

Morristown, New Jersey, United States

Site Status

Dermatology Group, P.C.

Verona, New Jersey, United States

Site Status

Mount Sinai Medical Center

New York, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Long Island Skin Cancer and Dermatologic Surgery

Smithtown, New York, United States

Site Status

University of North Carolina At Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

The Skin Surgery Center

Winston-Salem, North Carolina, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Ohio State University; Comp Can Ctr

Columbus, Ohio, United States

Site Status

University of Oklahoma Health Sciences Cente; Department of Dermatology

Oklahoma City, Oklahoma, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Dermatology and Laser Center of Charleston PA

Charleston, South Carolina, United States

Site Status

The Sarah Cannon Research Inst

Nashville, Tennessee, United States

Site Status

DermSurgery Associates, PA

Houston, Texas, United States

Site Status

South Texas Research Alliance LLC

Laredo, Texas, United States

Site Status

South Valley Dermatology Center

West Jordan, Utah, United States

Site Status

Dermatology Associates PLLC

Seattle, Washington, United States

Site Status

Huntington Internal Medicine Group

Huntington, West Virginia, United States

Site Status

Manish J. Gharia, MD

Brookfield, Wisconsin, United States

Site Status

Alma M Cruz MD

Carolina, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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ML28296

Identifier Type: -

Identifier Source: org_study_id

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