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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 November 2014 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01604252
First received: May 21, 2012
Last updated: November 4, 2014
Last verified: November 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, 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


Estimated Enrollment: 750
Study Start Date: June 2012
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

  Show 79 Study Locations
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: November 4, 2014
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 November 20, 2014