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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)

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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
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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Brief Summary:
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 or disease
Basal Cell Carcinoma

Study Design
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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

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Groups and Cohorts
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Group/Cohort
Cohort


Outcome Measures
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Primary Outcome Measures :
  1. Response rate [ Time Frame: approximately 5 years ]
  2. Duration of response [ Time Frame: approximately 5 years ]
  3. Recurrence rate [ Time Frame: approximately 5 years ]
  4. Progression-free survival [ Time Frame: approximately 5 years ]
  5. Overall survival [ Time Frame: approximately 5 years ]
  6. Safety: Incidence of adverse events [ Time Frame: approximately 5 years ]

Biospecimen Retention:   Samples With DNA
optional blood sample

Eligibility Criteria
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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
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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Information from the National Library of Medicine

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


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Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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