Basal Cell Carcinoma Clinical Trial
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
| Verified date | June 2017 |
| Source | Genentech, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 503 |
| Est. completion date | April 28, 2017 |
| Est. primary completion date | April 28, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Alma M Cruz MD | Carolina | |
| United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
| United States | Georgia Skin Cancer and Aesthetic Dermatology | Athens | Georgia |
| United States | Emory Univ Winship Cancer Inst | Atlanta | Georgia |
| United States | University of Colorado; Anschutz Cancer Pavilion | Aurora | Colorado |
| United States | Beverly Hospital, A Member of Lahey Health | Beverly | Massachusetts |
| United States | Moy-Fincher-Chipps Facial Plastics and Dermatology | Beverly Hills | California |
| United States | Manish J. Gharia, MD | Brookfield | Wisconsin |
| United States | Cooper University Hospital | Camden | New Jersey |
| United States | Laser & Skin Surgery Center of Indiana | Carmel | Indiana |
| United States | Shideler Clinical Research Center | Carmel | Indiana |
| United States | University of North Carolina At Chapel Hill | Chapel Hill | North Carolina |
| United States | Dermatology and Laser Center of Charleston PA | Charleston | South Carolina |
| United States | Laser and Dermatologic Surgery Center | Chesterfield | Missouri |
| United States | Northwestern University | Chicago | Illinois |
| United States | Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Ohio State University; Comp Can Ctr | Columbus | Ohio |
| United States | Dermatology Associates and Research | Coral Gables | Florida |
| United States | MLF Knuckles, MD, PSC | Corbin | Kentucky |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | NOVA Southeastern University | Fort Lauderdale | Florida |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | Associated Dermatology and Skin Cancer Clinic of Helena, PC | Helena | Montana |
| United States | Bettencourt Skin Center | Henderson | Nevada |
| United States | Hollywood Dermatology and Cosmetic Specialists | Hollywood | Florida |
| United States | DermSurgery Associates, PA | Houston | Texas |
| United States | Huntington Internal Medicine Group | Huntington | West Virginia |
| United States | University of California Irvine | Irvine | California |
| United States | University of Mississippi Medical Center; Division of Dermatology | Jackson | Mississippi |
| United States | Mayo Clinic-Jacksonville | Jacksonville | Florida |
| United States | Faulkner Hospital | Jamaica Plain | Massachusetts |
| United States | Scripps Clinic; Hematology & Oncology | La Jolla | California |
| United States | University of California San Diego | La Jolla | California |
| United States | South Texas Research Alliance LLC | Laredo | Texas |
| United States | Linda Woodson Dermatology, A Professional Corporation | Las Vegas | Nevada |
| United States | Strimling Dermatology, Laser and Vein Institute | Las Vegas | Nevada |
| United States | Woodson Dermatology | Las Vegas | Nevada |
| United States | Fairmont Dermatology Medical Associates, Inc. | Lodi | California |
| United States | Loma Linda University Medical Center | Loma Linda | California |
| United States | Dermatology Research Associate | Los Angeles | California |
| United States | Derm Research, LLC | Louisville | Kentucky |
| United States | Dermatologic Surgery Specialists, Inc | Macon | Georgia |
| United States | Northwest Georgia Dermatology and Skin Cancer Specialists | Marietta | Georgia |
| United States | University of Miami | Miami | Florida |
| United States | University of Minnesota. | Minneapolis | Minnesota |
| United States | Atlantic Health System | Morristown | New Jersey |
| United States | The Sarah Cannon Research Inst | Nashville | Tennessee |
| United States | Columbia University Medical Center | New York | New York |
| United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
| United States | Mount Sinai Medical Center | New York | New York |
| United States | Newport Dermatology and Laser Associates | Newport Beach | California |
| United States | University of Oklahoma Health Sciences Cente; Department of Dermatology | Oklahoma City | Oklahoma |
| United States | Advanced Derm & Cosmetic Surg | Ormond Beach | Florida |
| United States | Stanford University | Palo Alto | California |
| United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
| United States | Belleair Research Center | Pinellas Park | Florida |
| United States | Indiana Clinical Trial Center | Plainfield | Indiana |
| United States | Skin and Cancer Associates and the Center for Cosmetic Enhancement | Plantation | Florida |
| United States | Skin Cancer and Dermatology Institute | Reno | Nevada |
| United States | University of Rochester | Rochester | New York |
| United States | Saint Louis University School of Medicine; Department of Dermatology | Saint Louis | Missouri |
| United States | Spencer Derma & Skin Surg Ctr | Saint Petersburg | Florida |
| United States | Skin Surgery Med Group, Inc | San Diego | California |
| United States | University Clinical Trials | San Diego | California |
| United States | Clinical Research Specialists, Inc. | Santa Monica | California |
| United States | California Pacific Medical Center Research Institute | Santa Rosa | California |
| United States | Mayo Clinic | Scottsdale | Arizona |
| United States | Dermatology Associates PLLC | Seattle | Washington |
| United States | Florida Research Specialists | Seminole | Florida |
| United States | Long Island Skin Cancer and Dermatologic Surgery | Smithtown | New York |
| United States | Gwinnett Clinical Research Center | Snellville | Georgia |
| United States | Southern IL Univ School of Med | Springfield | Illinois |
| United States | H. Lee Moffitt Cancer Center and Research Inst. | Tampa | Florida |
| United States | University of South Florida | Tampa | Florida |
| United States | Pacific Dermatology Institute | Temecula | California |
| United States | Arizona Cancer Center | Tucson | Arizona |
| United States | Advanced Derm & Cosmetic Care | Valencia | California |
| United States | Dermatology Group, P.C. | Verona | New Jersey |
| United States | South Valley Dermatology Center | West Jordan | Utah |
| United States | Kenneth R. Beer, M.D., PA | West Palm Beach | Florida |
| United States | The Skin Surgery Center | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Genentech, Inc. |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Response rate | approximately 5 years | ||
| Primary | Duration of response | approximately 5 years | ||
| Primary | Recurrence rate | approximately 5 years | ||
| Primary | Progression-free survival | approximately 5 years | ||
| Primary | Overall survival | approximately 5 years | ||
| Primary | Safety: Incidence of adverse events | approximately 5 years |
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