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Basal Cell CarcinomaNCT01604252

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

An observational study of Basal Cell Carcinoma, run by Genentech, Inc. at 81 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Basal Cell Carcinoma
How many people
503 participants
Where
81 sitesin 2 countries
Study dates
20 Jun 2012to 28 Apr 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients treated for advanced basal cell carcinoma and basal cell carcinoma nevus syndrome

Who may be able to join

  • 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))

Who cannot join

  • 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)

Trial locations and contacts

81 sites in 2 countries.

81 sites in 2 countries

United States80 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Georgia Skin Cancer and Aesthetic Dermatology

    Athens, Georgia, 30606

  • Emory Univ Winship Cancer Inst

    Atlanta, Georgia, 30322

  • University of Colorado; Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • Beverly Hospital, A Member of Lahey Health

    Beverly, Massachusetts, 01915

  • Moy-Fincher-Chipps Facial Plastics and Dermatology

    Beverly Hills, California, 90210

  • Manish J. Gharia, MD

    Brookfield, Wisconsin, 53045

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • Laser & Skin Surgery Center of Indiana

    Carmel, Indiana, 46032

  • Shideler Clinical Research Center

    Carmel, Indiana, 46032

  • University of North Carolina At Chapel Hill

    Chapel Hill, North Carolina, 27514

  • Dermatology and Laser Center of Charleston PA

    Charleston, South Carolina, 29414

  • Laser and Dermatologic Surgery Center

    Chesterfield, Missouri, 63017

  • Northwestern University

    Chicago, Illinois, 60611

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State University; Comp Can Ctr

    Columbus, Ohio, 43210

  • Dermatology Associates and Research

    Coral Gables, Florida, 33134

  • MLF Knuckles, MD, PSC

    Corbin, Kentucky, 40701

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • NOVA Southeastern University

    Fort Lauderdale, Florida, 33328

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Associated Dermatology and Skin Cancer Clinic of Helena, PC

    Helena, Montana, 59601

  • Bettencourt Skin Center

    Henderson, Nevada, 89074

  • Hollywood Dermatology and Cosmetic Specialists

    Hollywood, Florida, 33021

  • DermSurgery Associates, PA

    Houston, Texas, 77030

  • Huntington Internal Medicine Group

    Huntington, West Virginia, 25705

  • University of California Irvine

    Irvine, California, 92697

  • University of Mississippi Medical Center; Division of Dermatology

    Jackson, Mississippi, 39216

  • Mayo Clinic-Jacksonville

    Jacksonville, Florida, 32224

  • Faulkner Hospital

    Jamaica Plain, Massachusetts, 02130

  • Scripps Clinic; Hematology & Oncology

    La Jolla, California, 92037-1027

  • University of California San Diego

    La Jolla, California, 92093

  • South Texas Research Alliance LLC

    Laredo, Texas, 78041

  • Linda Woodson Dermatology, A Professional Corporation

    Las Vegas, Nevada, 89128

  • Woodson Dermatology

    Las Vegas, Nevada, 89128

  • Strimling Dermatology, Laser and Vein Institute

    Las Vegas, Nevada, 89144

  • Fairmont Dermatology Medical Associates, Inc.

    Lodi, California, 95242

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Dermatology Research Associate

    Los Angeles, California, 90045

  • Derm Research, LLC

    Louisville, Kentucky, 40217

  • Dermatologic Surgery Specialists, Inc

    Macon, Georgia, 31217

  • Northwest Georgia Dermatology and Skin Cancer Specialists

    Marietta, Georgia, 30060

  • University of Miami

    Miami, Florida, 33136

  • University of Minnesota.

    Minneapolis, Minnesota, 55454

  • Atlantic Health System

    Morristown, New Jersey, 07960

  • The Sarah Cannon Research Inst

    Nashville, Tennessee, 37203

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Memorial Sloan-Kettering Cancer Center

    New York, New York

  • Newport Dermatology and Laser Associates

    Newport Beach, California, 92660

  • University of Oklahoma Health Sciences Cente; Department of Dermatology

    Oklahoma City, Oklahoma, 73104

  • Advanced Derm & Cosmetic Surg

    Ormond Beach, Florida, 32174

  • Stanford University

    Palo Alto, California, 94304

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Belleair Research Center

    Pinellas Park, Florida, 33781

  • Indiana Clinical Trial Center

    Plainfield, Indiana, 46168

  • Skin and Cancer Associates and the Center for Cosmetic Enhancement

    Plantation, Florida, 33324

  • Skin Cancer and Dermatology Institute

    Reno, Nevada, 89509

  • University of Rochester

    Rochester, New York, 14623

  • Skin Surgery Med Group, Inc

    San Diego, California, 92117

  • University Clinical Trials

    San Diego, California, 92123

  • Clinical Research Specialists, Inc.

    Santa Monica, California, 90404-2115

  • California Pacific Medical Center Research Institute

    Santa Rosa, California, 95403

  • Mayo Clinic

    Scottsdale, Arizona, 85259

  • Dermatology Associates PLLC

    Seattle, Washington, 98101

  • Florida Research Specialists

    Seminole, Florida, 33708

  • Long Island Skin Cancer and Dermatologic Surgery

    Smithtown, New York, 11787

  • Gwinnett Clinical Research Center

    Snellville, Georgia, 30078

  • Southern IL Univ School of Med

    Springfield, Illinois, 62702

  • Saint Louis University School of Medicine; Department of Dermatology

    St Louis, Missouri, 63104

  • Spencer Derma & Skin Surg Ctr

    St. Petersburg, Florida, 33716

  • H. Lee Moffitt Cancer Center and Research Inst.

    Tampa, Florida, 33612

  • University of South Florida

    Tampa, Florida, 33612

  • Pacific Dermatology Institute

    Temecula, California, 92592

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • Advanced Derm & Cosmetic Care

    Valencia, California, 91355

  • Dermatology Group, P.C.

    Verona, New Jersey, 07044

  • South Valley Dermatology Center

    West Jordan, Utah, 84088

  • Kenneth R. Beer, M.D., PA

    West Palm Beach, Florida, 33401

  • The Skin Surgery Center

    Winston-Salem, North Carolina, 27106

Other trials in United States

Puerto Rico1 site

  • Alma M Cruz MD

    Carolina, 00985

Other trials in Puerto Rico

About this study

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

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.

Medical subject headings
Carcinoma, Basal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01604252
Study groupRoleWhat they receive
CohortNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

    Measured: approximately 5 years

  2. Duration of response

    Measured: approximately 5 years

  3. Recurrence rate

    Measured: approximately 5 years

  4. Progression-free survival

    Measured: approximately 5 years

  5. Overall survival

    Measured: approximately 5 years

  6. Safety: Incidence of adverse events

    Measured: approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2012 (estimated)
  2. Study start20 Jun 2012
  3. Primary completion28 Apr 2017
  4. Study completion28 Apr 2017

Why it stopped: The study was terminated early by the Sponsor due to the high rate of discontinuation of subjects unrelated to patient safety.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
503 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01604252
Sponsor's protocol ID
ML28296
Status last verified
Jun 2017
First submitted
21 May 2012
Last updated
28 Jul 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Basal Cell Carcinoma, run by Genentech, Inc. at 81 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The study was terminated early by the Sponsor due to the high rate of discontinuation of subjects unrelated to patient safety.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: approximately 5 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01604252.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.

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