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:
Genentech, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01604252
First received: May 21, 2012
Last updated: September 1, 2016
Last verified: September 2016
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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: | 503 |
| 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) |
| Groups/Cohorts |
|---|
| Cohort |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01604252
Show 78 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604252
Show 78 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
| Study Director: | Clinical Trials | Genentech, Inc. |
More Information
| 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, 2016 |
| 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 September 30, 2016