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

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:

MedlinePlus related topics: Birthmarks Moles

U.S. FDA Resources

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:	1000
Study Start Date:	June 2012
Estimated Study Completion Date:	October 2020
Estimated Primary Completion Date:	October 2020 (Final data collection date for primary outcome measure)

Groups/Cohorts
Cohort

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604252

Contacts

Contact: Please reference Study ID Number: ML28296 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Hide Study Locations

Locations

United States, Arizona
	Not yet recruiting
Scottsdale, Arizona, United States, 85259
United States, California
	Not yet recruiting
Beverly Hills, California, United States, 90210
	Recruiting
Beverly Hills, California, United States, 90210
	Not yet recruiting
Irvine, California, United States, 92697
	Not yet recruiting
La Jolla, California, United States, 92037-1027
	Not yet recruiting
Loma Linda, California, United States, 92354
	Recruiting
Los Angeles, California, United States, 90045
	Not yet recruiting
Palo Alto, California, United States, 94304
	Recruiting
San Diego, California, United States, 92123
	Recruiting
Santa Monica, California, United States, 90404-2115
	Not yet recruiting
Santa Rosa, California, United States, 95403
	Recruiting
Valencia, California, United States, 91355
United States, Colorado
	Not yet recruiting
Aurora, Colorado, United States, 80045
United States, Florida
	Recruiting
Hollywood, Florida, United States, 33021
	Recruiting
Ormond Beach, Florida, United States, 32174
	Recruiting
Plantation, Florida, United States, 33324
	Recruiting
Seminole, Florida, United States, 33708
	Recruiting
St. Petersburg, Florida, United States, 33716
	Not yet recruiting
Tampa, Florida, United States, 33647
	Recruiting
West Palm Beach, Florida, United States, 33401
United States, Georgia
	Not yet recruiting
Athens, Georgia, United States, 30606
	Recruiting
Macon, Georgia, United States, 31217
	Recruiting
Marietta, Georgia, United States, 30060
United States, Illinois
	Recruiting
Chicago, Illinois, United States, 60611
	Not yet recruiting
Springfield, Illinois, United States, 62702
United States, Indiana
	Recruiting
Carmel, Indiana, United States, 46032
	Not yet recruiting
Indianapolis, Indiana, United States, 46202
United States, Kentucky
	Recruiting
Louisville, Kentucky, United States, 40217
United States, Maryland
	Recruiting
St. Louis, Maryland, United States, 63104
United States, Massachusetts
	Not yet recruiting
Boston, Massachusetts, United States, 02111
	Not yet recruiting
Jamaica Plain, Massachusetts, United States, 02130
United States, Missouri
	Recruiting
Chesterfield, Missouri, United States, 63017
	Not yet recruiting
St. Louis, Missouri, United States, 63110
	Not yet recruiting
St. Louis, Missouri, United States, 63141
United States, Nebraska
	Not yet recruiting
Omaha, Nebraska, United States, 68114
United States, Nevada
	Not yet recruiting
Reno, Nevada, United States, 89509
United States, New Jersey
	Not yet recruiting
Morristown, New Jersey, United States, 07960
	Recruiting
Verona, New Jersey, United States, 07044
United States, New York
	Not yet recruiting
New York, New York, United States, 10065
	Not yet recruiting
New York, New York, United States, 10029
	Not yet recruiting
New York, New York, United States, 10032
	Not yet recruiting
Rochester, New York, United States, 14623
	Recruiting
Smithtown, New York, United States, 11787
United States, North Carolina
	Not yet recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
	Not yet recruiting
Cleveland, Ohio, United States, 44195
	Not yet recruiting
Columbus, Ohio, United States, 43210
United States, Oklahoma
	Not yet recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
	Not yet recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, South Carolina
	Recruiting
Charleston, South Carolina, United States, 29414
United States, Tennessee
	Not yet recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
	Recruiting
Houston, Texas, United States, 77030
United States, Washington
	Recruiting
Seattle, Washington, United States, 98101

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:	January 8, 2013
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 May 19, 2013