Genetic Predisposition Testing Program for Pancreatic Neuroendocrine Neoplasms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-07

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Collection of Clinical and Epidemiologic Data Combined With Tissue and Blood From Patients With a Diagnosis of Neuroendocrine Tumors

NCT00745381

Gastric Cancer Pancreatic Cancer

COMPLETED

DNA Microarray Study of Pancreas Cancer

NCT00680420

Pancreas Cancer

COMPLETED

Clinical Utility Assay as a Biomarker for Gastroenteropancreatic and Lung Neuroendocrine Tumors

NCT02948946

Gastroenteropancreatic Neuroendocrine Tumor Lung Neuroendocrine Neoplasm

COMPLETED

Prospective Comprehensive Molecular Profiling In Neuroendocrine Tumors

NCT02586844

Neuroendocrine Tumors Pancreatic Neuroendocrine Tumors

COMPLETED

Plasma cfDNA Fragmentomics for Early pNET Detection and Differential Diagnosis of Solid Pancreatic Tumors

NCT05847855

Pancreatic Neuroendocrine Tumor Solid Pancreatic Neoplasms

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Neuroendocrine Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Participants with Pancreatic Neuroendocrine Neoplasms

Hereditary Cancer Panel

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

University of California, San Francisco's (UCSF) Expanded Hereditary Cancer Panel Germline Testing

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No