2023-04-07
2025-12-31
2025-12-31
300
NCT05746182
University of California, San Francisco
University of California, San Francisco
OBSERVATIONAL
Genetic Predisposition Testing Program for Pancreatic Neuroendocrine Neoplasms
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)
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-02-17 | N/A | 2025-01-06 |
2023-02-17 | N/A | 2025-01-08 |
2023-02-27 | N/A | 2024-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Participants with Pancreatic Neuroendocrine Neoplasms | DIAGNOSTIC_TEST: Hereditary Cancer Panel
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Rate of overall pathogenic germline mutations | The overall percentage of participants with pathogenic, or likely pathogenic germline mutations will be reported with 95% confidence intervals | Up to 2 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Rates of different types of pathogenic mutations | The percentage of participants with each identified type of pathogenic, or likely pathogenic, will be reported with 95% confidence intervals | Up to 2 years |
| Rates of different types of variants of uncertain significance (VUS) | The percentage of participants with identified variants of uncertain significance will be reported with 95% confidence intervals. | Up to 2 years |
| Rate of declination for participants offered testing. | Participants who decline genetic testing but agree to participate in other study procedures will complete a Declination Survey which consists of one questions asking the reason for the decision to decline germline testing. | Up to 2 years |
| Rate of completion of testing | The rate of study completion defined as the percentage of participants who agree to testing, and complete all study procedures through return of results and meeting with genetic counselor (as appropriate) will be reported. | Up to 2 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Bryan Le Phone Number: (415) 502-6313 Email: bryankhuong.le@ucsf.edu |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
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