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 currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01604252
First received: May 21, 2012
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

This multi-center, prospective, observational cohort study will evaluate the eff ectiveness, safety and utilization of treatments in patients with advanced basal cell carcinoma and basal cell carcinoma nevus syndrome. The total study duratio n is anticipated to be a maximum of 8 years, including 3 years for patient recru itment 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:

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


Estimated Enrollment: 750
Study Start Date: March 2014
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2020 (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

Contacts
Contact: Reference Study ID Number: ML28296 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
United States, Arizona
Recruiting
Scottsdale, Arizona, United States, 85259
Recruiting
Tucson, Arizona, United States, 85724
United States, California
Terminated
Beverly Hills, California, United States, 90210
Recruiting
Irvine, California, United States, 92697
Recruiting
La Jolla, California, United States, 92037-1027
Recruiting
La Jolla, California, United States, 92093
Recruiting
Lodi, California, United States, 95242
Recruiting
Loma Linda, California, United States, 92354
Recruiting
Los Angeles, California, United States, 90045
Recruiting
Newport Beach, California, United States, 92660
Recruiting
Palo Alto, California, United States, 94304
Recruiting
San Diego, California, United States, 92117
Recruiting
San Diego, California, United States, 92123
Recruiting
Santa Monica, California, United States, 90404-2115
Recruiting
Santa Rosa, California, United States, 95403
Recruiting
Temecula, California, United States, 92592
Recruiting
Valencia, California, United States, 91355
United States, Colorado
Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Recruiting
Coral Gables, Florida, United States, 33134
Recruiting
Fort Lauderdale, Florida, United States, 33328
Active, not recruiting
Hollywood, Florida, United States, 33021
Recruiting
Jacksonville, Florida, United States, 32224
Recruiting
Miami, Florida, United States, 33136
Recruiting
Ormond Beach, Florida, United States, 32174
Recruiting
Pinellas Park, Florida, United States, 33781
Active, not recruiting
Plantation, Florida, United States, 33324
Recruiting
Seminole, Florida, United States, 33708
Recruiting
St. Petersburg, Florida, United States, 33716
Recruiting
Tampa, Florida, United States, 33612
Terminated
West Palm Beach, Florida, United States, 33401
United States, Georgia
Recruiting
Athens, Georgia, United States, 30606
Recruiting
Macon, Georgia, United States, 31217
Recruiting
Marietta, Georgia, United States, 30060
Recruiting
Snellville, Georgia, United States, 30078
United States, Illinois
Recruiting
Chicago, Illinois, United States, 60611
Recruiting
Springfield, Illinois, United States, 62702
United States, Indiana
Terminated
Carmel, Indiana, United States, 46032
Recruiting
Carmel, Indiana, United States, 46032
Recruiting
Plainfield, Indiana, United States, 46168
United States, Kentucky
Recruiting
Corbin, Kentucky, United States, 40701
Recruiting
Louisville, Kentucky, United States, 40217
United States, Massachusetts
Recruiting
Beverly, Massachusetts, United States, 01915
Recruiting
Jamaica Plain, Massachusetts, United States, 02130
United States, Michigan
Recruiting
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Recruiting
Minneapolis, Minnesota, United States, 55454
United States, Mississippi
Recruiting
Jackson, Mississippi, United States, 39216
United States, Missouri
Recruiting
Chesterfield, Missouri, United States, 63017
Recruiting
St. Louis, Missouri, United States, 63104
United States, Montana
Recruiting
Helena, Montana, United States, 59601
United States, Nevada
Recruiting
Henderson, Nevada, United States, 89074
Recruiting
Las Vegas, Nevada, United States, 89144
Recruiting
Las Vegas, Nevada, United States, 89128
Terminated
Reno, Nevada, United States, 89509
United States, New Jersey
Recruiting
Camden, New Jersey, United States, 08103
Recruiting
Hackensack, New Jersey, United States, 07601
Recruiting
Morristown, New Jersey, United States, 07960
Recruiting
Verona, New Jersey, United States, 07044
United States, New York
Recruiting
New York, New York, United States, 10032
Recruiting
New York, New York, United States, 10065
Recruiting
New York, New York, United States, 10029
Recruiting
Rochester, New York, United States, 14623
Recruiting
Smithtown, New York, United States, 11787
United States, North Carolina
Recruiting
Chapel Hill, North Carolina, United States, 27514
Recruiting
Durham, North Carolina, United States, 27710
Recruiting
Winston-Salem, North Carolina, United States, 27106
United States, Ohio
Recruiting
Cleveland, Ohio, United States, 44195
Recruiting
Columbus, Ohio, United States, 43210
United States, Oklahoma
Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, South Carolina
Recruiting
Charleston, South Carolina, United States, 29414
United States, Tennessee
Terminated
Nashville, Tennessee, United States, 37203
United States, Texas
Not yet recruiting
Houston, Texas, United States, 77030-4095
Terminated
Houston, Texas, United States, 77030
Terminated
Laredo, Texas, United States, 78041
United States, Utah
Terminated
West Jordan, Utah, United States, 84088
United States, Washington
Terminated
Seattle, Washington, United States, 98101
United States, West Virginia
Recruiting
Huntington, West Virginia, United States, 25705
United States, Wisconsin
Recruiting
Brookfield, Wisconsin, United States, 53045
Puerto Rico
Recruiting
Carolina, Puerto Rico, 00985
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01604252     History of Changes
Other Study ID Numbers: ML28296
Study First Received: May 21, 2012
Last Updated: August 20, 2014
Health Authority: United States: Institutional Review Board

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 28, 2014