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



Status:Active, not recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/3/2016
Start Date:June 2012
End Date:August 2018

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A Prospective Observational Study of Treatment Patterns and Effectiveness and Safety Outcomes in Advanced Basal Cell Carcinoma and Basal Cell Carcinoma Nevus Syndrome Patients

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.


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)
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