Clinical trial NCT01604252: An Observational Study of Treatment Patterns and Effectiveness and Safety Outcomes in Advanced Basal Cell Carcinoma and Basal Cell Carcinoma Nevus Syndrome Patients(RegiSONIC)
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Basal Cell Carcinoma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-23
Enrollment: 503
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated for advanced basal cell carcinoma and basal cell carcinoma nevus syndrome

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.


Eligibility 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)

Primary outcomes:
measure: Response rate
timeFrame: approximately 5 years
measure: Duration of response
timeFrame: approximately 5 years
measure: Recurrence rate
timeFrame: approximately 5 years
measure: Progression-free survival
timeFrame: approximately 5 years
measure: Overall survival
timeFrame: approximately 5 years
measure: Safety: Incidence of adverse events
timeFrame: approximately 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Beverly Hills
country: United States
facility: Moy-Fincher-Chipps Facial Plastics and Dermatology
state: California
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: La Jolla
country: United States
facility: Scripps Clinic; Hematology & Oncology
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Lodi
country: United States
facility: Fairmont Dermatology Medical Associates, Inc.
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associate
state: California
city: Newport Beach
country: United States
facility: Newport Dermatology and Laser Associates
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Diego
country: United States
facility: Skin Surgery Med Group, Inc
state: California
city: San Diego
country: United States
facility: University Clinical Trials
state: California
city: Santa Monica
country: United States
facility: Clinical Research Specialists, Inc.
state: California
city: Santa Rosa
country: United States
facility: California Pacific Medical Center Research Institute
state: California
city: Temecula
country: United States
facility: Pacific Dermatology Institute
state: California
city: Valencia
country: United States
facility: Advanced Derm & Cosmetic Care
state: California
city: Aurora
country: United States
facility: University of Colorado; Anschutz Cancer Pavilion
state: Colorado
city: Coral Gables
country: United States
facility: Dermatology Associates and Research
state: Florida
city: Fort Lauderdale
country: United States
facility: NOVA Southeastern University
state: Florida
city: Hollywood
country: United States
facility: Hollywood Dermatology and Cosmetic Specialists
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic-Jacksonville
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Ormond Beach
country: United States
facility: Advanced Derm & Cosmetic Surg
state: Florida
city: Pinellas Park
country: United States
facility: Belleair Research Center
state: Florida
city: Plantation
country: United States
facility: Skin and Cancer Associates and the Center for Cosmetic Enhancement
state: Florida
city: Saint Petersburg
country: United States
facility: Spencer Derma & Skin Surg Ctr
state: Florida
city: Seminole
country: United States
facility: Florida Research Specialists
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Inst.
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: West Palm Beach
country: United States
facility: Kenneth R. Beer, M.D., PA
state: Florida
city: Athens
country: United States
facility: Georgia Skin Cancer and Aesthetic Dermatology
state: Georgia
city: Atlanta
country: United States
facility: Emory Univ Winship Cancer Inst
state: Georgia
city: Macon
country: United States
facility: Dermatologic Surgery Specialists, Inc
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Dermatology and Skin Cancer Specialists
state: Georgia
city: Snellville
country: United States
facility: Gwinnett Clinical Research Center
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Springfield
country: United States
facility: Southern IL Univ School of Med
state: Illinois
city: Carmel
country: United States
facility: Laser & Skin Surgery Center of Indiana
state: Indiana
city: Carmel
country: United States
facility: Shideler Clinical Research Center
state: Indiana
city: Plainfield
country: United States
facility: Indiana Clinical Trial Center
state: Indiana
city: Corbin
country: United States
facility: MLF Knuckles, MD, PSC
state: Kentucky
city: Louisville
country: United States
facility: Derm Research, LLC
state: Kentucky
city: Beverly
country: United States
facility: Beverly Hospital, A Member of Lahey Health
state: Massachusetts
city: Jamaica Plain
country: United States
facility: Faulkner Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota.
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center; Division of Dermatology
state: Mississippi
city: Chesterfield
country: United States
facility: Laser and Dermatologic Surgery Center
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University School of Medicine; Department of Dermatology
state: Missouri
city: Helena
country: United States
facility: Associated Dermatology and Skin Cancer Clinic of Helena, PC
state: Montana
city: Henderson
country: United States
facility: Bettencourt Skin Center
state: Nevada
city: Las Vegas
country: United States
facility: Linda Woodson Dermatology, A Professional Corporation
state: Nevada
city: Las Vegas
country: United States
facility: Woodson Dermatology
state: Nevada
city: Las Vegas
country: United States
facility: Strimling Dermatology, Laser and Vein Institute
state: Nevada
city: Reno
country: United States
facility: Skin Cancer and Dermatology Institute
state: Nevada
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Atlantic Health System
state: New Jersey
city: Verona
country: United States
facility: Dermatology Group, P.C.
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Smithtown
country: United States
facility: Long Island Skin Cancer and Dermatologic Surgery
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina At Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: The Skin Surgery Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University; Comp Can Ctr
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Cente; Department of Dermatology
state: Oklahoma
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Dermatology and Laser Center of Charleston PA
state: South Carolina
city: Nashville
country: United States
facility: The Sarah Cannon Research Inst
state: Tennessee
city: Houston
country: United States
facility: DermSurgery Associates, PA
state: Texas
city: Laredo
country: United States
facility: South Texas Research Alliance LLC
state: Texas
city: West Jordan
country: United States
facility: South Valley Dermatology Center
state: Utah
city: Seattle
country: United States
facility: Dermatology Associates PLLC
state: Washington
city: Huntington
country: United States
facility: Huntington Internal Medicine Group
state: West Virginia
city: Brookfield
country: United States
facility: Manish J. Gharia, MD
state: Wisconsin
city: Carolina
country: Puerto Rico
facility: Alma M Cruz MD
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: