An Observational Study of Treatment Patterns and Effectiveness and Safety Outcomes in Advanced Basal Cell Carcinoma and Basal Cell Carcinoma Nevus Syndrome Patients(RegiSONIC)
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ClinicalTrials.gov Identifier: NCT01604252 |
Recruitment Status
:
Terminated
(The study was terminated early by the Sponsor due to the high rate of discontinuation of subjects unrelated to patient safety.)
First Posted
: May 23, 2012
Last Update Posted
: July 28, 2017
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Condition or disease |
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Basal Cell Carcinoma |
Study Type : | Observational |
Actual Enrollment : | 503 participants |
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 |
Actual Study Start Date : | June 20, 2012 |
Actual Primary Completion Date : | April 28, 2017 |
Actual Study Completion Date : | April 28, 2017 |
Group/Cohort |
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Cohort |
- Response rate [ Time Frame: approximately 5 years ]
- Duration of response [ Time Frame: approximately 5 years ]
- Recurrence rate [ Time Frame: approximately 5 years ]
- Progression-free survival [ Time Frame: approximately 5 years ]
- Overall survival [ Time Frame: approximately 5 years ]
- Safety: Incidence of adverse events [ Time Frame: approximately 5 years ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Adult patients, >/= 18 years of age
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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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604252

Study Director: | Clinical Trials | Genentech, Inc. |
Responsible Party: | Genentech, Inc. |
ClinicalTrials.gov Identifier: | NCT01604252 History of Changes |
Other Study ID Numbers: |
ML28296 |
First Posted: | May 23, 2012 Key Record Dates |
Last Update Posted: | July 28, 2017 |
Last Verified: | June 2017 |
Additional relevant MeSH terms:
Carcinoma Carcinoma, Basal Cell Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Basal Cell |