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 September 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01604252
First received: May 21, 2012
Last updated: September 15, 2014
Last verified: September 2014

May 21, 2012
September 15, 2014
March 2014
September 2020   (final data collection date for primary outcome measure)
  • 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 ]
  • Objective response rate [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Duration of objective 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 ]
Complete list of historical versions of study NCT01604252 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
An Observational Study of Treatment Patterns and Effectiveness and Safety Outcomes in Advanced Basal Cell Carcinoma and Basal Cell Carcinoma Nevus Syndrome Patients(RegiSONIC)
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 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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

optional blood sample

Probability Sample

Patients treated for advanced basal cell carcinoma and basal cell carcinoma nevus syndrome

Basal Cell Carcinoma
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
750
September 2020
September 2020   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Reference Study ID Number: ML28296 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   Puerto Rico
 
NCT01604252
ML28296
Not Provided
Genentech
Genentech
Not Provided
Study Director: Clinical Trials Genentech
Genentech
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP