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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01604252
First received: May 21, 2012
Last updated: September 1, 2015
Last verified: September 2015
  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 ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Recurrence rate [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

optional blood sample


Enrollment: 492
Study Start Date: June 2012
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Scottsdale, Arizona, United States, 85259
Tucson, Arizona, United States, 85724
United States, California
Beverly Hills, California, United States, 90210
Irvine, California, United States, 92697
La Jolla, California, United States, 92037-1027
La Jolla, California, United States, 92093
Lodi, California, United States, 95242
Loma Linda, California, United States, 92354
Los Angeles, California, United States, 90045
Newport Beach, California, United States, 92660
Palo Alto, California, United States, 94304
San Diego, California, United States, 92117
San Diego, California, United States, 92123
Santa Monica, California, United States, 90404-2115
Santa Rosa, California, United States, 95403
Temecula, California, United States, 92592
Valencia, California, United States, 91355
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Coral Gables, Florida, United States, 33134
Fort Lauderdale, Florida, United States, 33328
Hollywood, Florida, United States, 33021
Jacksonville, Florida, United States, 32224
Miami, Florida, United States, 33136
Ormond Beach, Florida, United States, 32174
Pinellas Park, Florida, United States, 33781
Plantation, Florida, United States, 33324
Seminole, Florida, United States, 33708
St. Petersburg, Florida, United States, 33716
Tampa, Florida, United States, 33612
West Palm Beach, Florida, United States, 33401
United States, Georgia
Athens, Georgia, United States, 30606
Atlanta, Georgia, United States, 30322
Macon, Georgia, United States, 31217
Marietta, Georgia, United States, 30060
Snellville, Georgia, United States, 30078
United States, Illinois
Chicago, Illinois, United States, 60611
Springfield, Illinois, United States, 62702
United States, Indiana
Carmel, Indiana, United States, 46032
Plainfield, Indiana, United States, 46168
United States, Kentucky
Corbin, Kentucky, United States, 40701
Louisville, Kentucky, United States, 40217
United States, Massachusetts
Beverly, Massachusetts, United States, 01915
Jamaica Plain, Massachusetts, United States, 02130
United States, Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Minneapolis, Minnesota, United States, 55454
United States, Mississippi
Jackson, Mississippi, United States, 39216
United States, Missouri
Chesterfield, Missouri, United States, 63017
St. Louis, Missouri, United States, 63104
United States, Montana
Helena, Montana, United States, 59601
United States, Nevada
Henderson, Nevada, United States, 89074
Las Vegas, Nevada, United States, 89128
Las Vegas, Nevada, United States, 89144
Reno, Nevada, United States, 89509
United States, New Jersey
Camden, New Jersey, United States, 08103
Hackensack, New Jersey, United States, 07601
Morristown, New Jersey, United States, 07960
Verona, New Jersey, United States, 07044
United States, New York
New York, New York, United States, 10029
New York, New York, United States, 10065
New York, New York, United States, 10032
Rochester, New York, United States, 14623
Smithtown, New York, United States, 11787
United States, North Carolina
Chapel Hill, North Carolina, United States, 27514
Durham, North Carolina, United States, 27710
Winston-Salem, North Carolina, United States, 27106
United States, Ohio
Cleveland, Ohio, United States, 44195
Columbus, Ohio, United States, 43210
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19111
United States, South Carolina
Charleston, South Carolina, United States, 29414
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Houston, Texas, United States, 77030-4095
Houston, Texas, United States, 77030
Laredo, Texas, United States, 78041
United States, Utah
West Jordan, Utah, United States, 84088
United States, Washington
Seattle, Washington, United States, 98101
United States, West Virginia
Huntington, West Virginia, United States, 25705
United States, Wisconsin
Brookfield, Wisconsin, United States, 53045
Puerto Rico
Carolina, Puerto Rico, 00985
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01604252     History of Changes
Other Study ID Numbers: ML28296
Study First Received: May 21, 2012
Last Updated: September 1, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 01, 2015