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

July 25, 2017 updated by: Genentech, Inc.

A Prospective Observational Study of Treatment Patterns and Effectiveness and Safety Outcomes in Advanced Basal Cell Carcinoma and Basal Cell Carcinoma Nevus Syndrome Patients

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.

Study Overview

Status

Terminated

Study Type

Observational

Enrollment (Actual)

503

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Carolina, Puerto Rico, 00985
        • Alma M Cruz MD
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center
    • California
      • Beverly Hills, California, United States, 90210
        • Moy-Fincher-Chipps Facial Plastics and Dermatology
      • Irvine, California, United States, 92697
        • University of California Irvine
      • La Jolla, California, United States, 92093
        • University Of California San Diego
      • La Jolla, California, United States, 92037-1027
        • Scripps Clinic; Hematology & Oncology
      • Lodi, California, United States, 95242
        • Fairmont Dermatology Medical Associates, Inc.
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associate
      • Newport Beach, California, United States, 92660
        • Newport Dermatology and Laser Associates
      • Palo Alto, California, United States, 94304
        • Stanford University
      • San Diego, California, United States, 92123
        • University Clinical Trials
      • San Diego, California, United States, 92117
        • Skin Surgery Med Group, Inc
      • Santa Monica, California, United States, 90404-2115
        • Clinical Research Specialists, Inc.
      • Santa Rosa, California, United States, 95403
        • California Pacific Medical Center Research Institute
      • Temecula, California, United States, 92592
        • Pacific Dermatology Institute
      • Valencia, California, United States, 91355
        • Advanced Derm & Cosmetic Care
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado; Anschutz Cancer Pavilion
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Dermatology Associates and Research
      • Fort Lauderdale, Florida, United States, 33328
        • Nova Southeastern University
      • Hollywood, Florida, United States, 33021
        • Hollywood Dermatology and Cosmetic Specialists
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic-Jacksonville
      • Miami, Florida, United States, 33136
        • University of Miami
      • Ormond Beach, Florida, United States, 32174
        • Advanced Derm & Cosmetic Surg
      • Pinellas Park, Florida, United States, 33781
        • Belleair Research Center
      • Plantation, Florida, United States, 33324
        • Skin and Cancer Associates and the Center for Cosmetic Enhancement
      • Saint Petersburg, Florida, United States, 33716
        • Spencer Derma & Skin Surg Ctr
      • Seminole, Florida, United States, 33708
        • Florida Research Specialists
      • Tampa, Florida, United States, 33612
        • University of South Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Inst.
      • West Palm Beach, Florida, United States, 33401
        • Kenneth R. Beer, M.D., PA
    • Georgia
      • Athens, Georgia, United States, 30606
        • Georgia Skin Cancer and Aesthetic Dermatology
      • Atlanta, Georgia, United States, 30322
        • Emory Univ Winship Cancer Inst
      • Macon, Georgia, United States, 31217
        • Dermatologic Surgery Specialists, Inc
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Dermatology and Skin Cancer Specialists
      • Snellville, Georgia, United States, 30078
        • Gwinnett Clinical Research Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Springfield, Illinois, United States, 62702
        • Southern IL Univ School of Med
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Laser & Skin Surgery Center of Indiana
      • Carmel, Indiana, United States, 46032
        • Shideler Clinical Research Center
      • Plainfield, Indiana, United States, 46168
        • Indiana Clinical Trial Center
    • Kentucky
      • Corbin, Kentucky, United States, 40701
        • MLF Knuckles, MD, PSC
      • Louisville, Kentucky, United States, 40217
        • Derm Research, LLC
    • Massachusetts
      • Beverly, Massachusetts, United States, 01915
        • Beverly Hospital, A Member of Lahey Health
      • Jamaica Plain, Massachusetts, United States, 02130
        • Faulkner Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • University of Minnesota.
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center; Division of Dermatology
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Laser and Dermatologic Surgery Center
      • Saint Louis, Missouri, United States, 63104
        • Saint Louis University School of Medicine; Department of Dermatology
    • Montana
      • Helena, Montana, United States, 59601
        • Associated Dermatology and Skin Cancer Clinic of Helena, PC
    • Nevada
      • Henderson, Nevada, United States, 89074
        • Bettencourt Skin Center
      • Las Vegas, Nevada, United States, 89128
        • Linda Woodson Dermatology, A Professional Corporation
      • Las Vegas, Nevada, United States, 89128
        • Woodson Dermatology
      • Las Vegas, Nevada, United States, 89144
        • Strimling Dermatology, Laser and Vein Institute
      • Reno, Nevada, United States, 89509
        • Skin Cancer and Dermatology Institute
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Morristown, New Jersey, United States, 07960
        • Atlantic Health System
      • Verona, New Jersey, United States, 07044
        • Dermatology Group, P.C.
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • New York, New York, United States
        • Memorial Sloan-Kettering Cancer Center
      • Rochester, New York, United States, 14623
        • University of Rochester
      • Smithtown, New York, United States, 11787
        • Long Island Skin Cancer and Dermatologic Surgery
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina at Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States, 27106
        • The Skin Surgery Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • Ohio State University; Comp Can Ctr
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Cente; Department of Dermatology
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Dermatology and Laser Center of Charleston PA
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • The Sarah Cannon Research Inst
    • Texas
      • Houston, Texas, United States, 77030
        • DermSurgery Associates, PA
      • Laredo, Texas, United States, 78041
        • South Texas Research Alliance LLC
    • Utah
      • West Jordan, Utah, United States, 84088
        • South Valley Dermatology Center
    • Washington
      • Seattle, Washington, United States, 98101
        • Dermatology Associates PLLC
    • West Virginia
      • Huntington, West Virginia, United States, 25705
        • Huntington Internal Medicine Group
    • Wisconsin
      • Brookfield, Wisconsin, United States, 53045
        • Manish J. Gharia, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: approximately 5 years
approximately 5 years
Duration of response
Time Frame: approximately 5 years
approximately 5 years
Recurrence rate
Time Frame: approximately 5 years
approximately 5 years
Progression-free survival
Time Frame: approximately 5 years
approximately 5 years
Overall survival
Time Frame: approximately 5 years
approximately 5 years
Safety: Incidence of adverse events
Time Frame: approximately 5 years
approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2012

Primary Completion (Actual)

April 28, 2017

Study Completion (Actual)

April 28, 2017

Study Registration Dates

First Submitted

May 21, 2012

First Submitted That Met QC Criteria

May 21, 2012

First Posted (Estimate)

May 23, 2012

Study Record Updates

Last Update Posted (Actual)

July 28, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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