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Clinical Trial Summary

This is a prospective observational multi-center pilot study of germline testing for participants receiving care at University of California participating locations with a new or existing diagnosis of Pancreatic Neuroendocrine Neoplasms (PanNEN). This protocol is an extension of existing Genetic Testing Station efforts at University of California, San Francisco (UCSF)


Clinical Trial Description

PRIMARY OBJECTIVE: I. To assess the frequency of germline mutations in patients with PanNEN. SECONDARY OBJECTIVES: I. To assess the rates of different types of germline mutations in patients PanNEN. II. To assess the rates of different types of variants of uncertain significance in patients with PanNEN. III. To estimate the rate of completion of genetic testing in patients who are offered prospective germline testing. EXPLORATORY OBJECTIVES: I. To examine attitudes of patients who have completed germline testing. II. To explore reasons for declining germline testing. III. In patients with repeat germline testing, compare the frequency of germline alteration between tests. IV. Assess the relationship between germline pathogenic variants and somatic mutations in PanNEN. OUTLINE: Potential eligible participants will be identified via chart review and invited to consent to the study. Study participants who agree to prospective testing and have not had previous large panel germline testing will watch an informational video about germline testing and be offered testing with University of California, San Francisco's (UCSF) Expanded Hereditary Cancer Panel. Study participants who decline germline testing will be asked to answer a one-question Declination Survey. Results will be shared with participants and their providers per the standard of practice at each participating study site. All participants who decided to receive germline testing will be asked to complete a decision survey. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05746182
Study type Observational
Source University of California, San Francisco
Contact Paige Steiding
Phone (415) 514-6314
Email Paige.Steiding@ucsf.edu
Status Recruiting
Phase
Start date April 7, 2023
Completion date December 31, 2025