Genetic Predisposition Testing Program for Pancreatic Neuroendocrine Neoplasms

Study Purpose

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)

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Histologically confirmed PanNEN. a. The diagnostic biopsy may have been taken from any site (primary or metastatic). 2. New and existing PanNEN participants will be eligible (any grade, any stage, any age > 18 years). 3. Participants willing and able to comply with the study procedures.

Exclusion Criteria:

1. Inability to provide informed consent. 2. For participants who have not had prior testing with a dedicated germline pane of at least 80 genes: 1. Inability to speak/read a language supported by the germline testing station (GTS). The supported languages currently include English, Korean, Japanese, Vietnamese, Russian, Tagalog, Farsi, Spanish, Cantonese, Mandarin, and Arabic). 2. Active hematologic malignancy. 3. History of allogenic bone marrow transplant or stem cell transplant.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05746182
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of California, San Francisco
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Emily Bergsland, MD
Principal Investigator Affiliation	University of California, San Francisco
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pancreatic Neuroendocrine Neoplasm

Additional Details

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.

Arms & Interventions

Arms

: Participants with Pancreatic Neuroendocrine Neoplasms

Interventions

Diagnostic Test: - Hereditary Cancer Panel

UCSF's Internal Clinical Laboratory Improvement Amendments of 1988 (CLIA)-certified Expanded Hereditary Cancer Panel will be employed which measures a minimum 88 genes

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California, Los Angeles, Los Angeles, California

Status

Recruiting

Address

University of California, Los Angeles

Los Angeles, California, 90095

Site Contact

[email protected]

(415) 514-6314

Univeristy of California, San Diego, San Diego, California

Status

Not yet recruiting

Address

Univeristy of California, San Diego

San Diego, California, 92093

Site Contact

[email protected]

(415) 514-6314

University of California, San Francisco, San Francisco, California

Status

Recruiting

Address

University of California, San Francisco

San Francisco, California, 94143

Site Contact

Paige Steiding

[email protected]

415-514-6314

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