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

This study has been terminated.
(The study was terminated early by the Sponsor due to the high rate of discontinuation of subjects unrelated to patient safety.)
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01604252
First received: May 21, 2012
Last updated: July 25, 2017
Last verified: June 2017
  Purpose
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.

Condition
Basal Cell Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study of Treatment Patterns and Effectiveness and Safety Outcomes in Advanced Basal Cell Carcinoma and Basal Cell Carcinoma Nevus Syndrome Patients

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Response rate [ Time Frame: approximately 5 years ]
  • Duration of response [ Time Frame: approximately 5 years ]
  • Recurrence rate [ Time Frame: approximately 5 years ]
  • Progression-free survival [ Time Frame: approximately 5 years ]
  • Overall survival [ Time Frame: approximately 5 years ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 5 years ]

Biospecimen Retention:   Samples With DNA
optional blood sample

Enrollment: 503
Actual Study Start Date: June 20, 2012
Study Completion Date: April 28, 2017
Primary Completion Date: April 28, 2017 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients treated for advanced basal cell carcinoma and basal cell carcinoma nevus syndrome
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604252

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

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01604252     History of Changes
Other Study ID Numbers: ML28296
Study First Received: May 21, 2012
Last Updated: July 25, 2017

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell

ClinicalTrials.gov processed this record on August 18, 2017