NCT05746182

Brief 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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Apr 2023Dec 2026

First Submitted

Initial submission to the registry

February 17, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 7, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

3.7 years

First QC Date

February 17, 2023

Last Update Submit

January 22, 2026

Conditions

Pancreatic Neuroendocrine Neoplasm

Keywords

Genetic AssayBiomarkers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Rates of different types of pathogenic mutations

    Up to 2 years

  • Rates of different types of variants of uncertain significance (VUS)

    Up to 2 years

  • Rate of declination for participants offered testing.

    Up to 2 years

  • Rate of completion of testing

    Up to 2 years

Study Arms (1)

Participants with Pancreatic Neuroendocrine Neoplasms

Diagnostic Test: Hereditary Cancer Panel

Interventions

Hereditary Cancer PanelDIAGNOSTIC_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

Also known as: University of California, San Francisco's (UCSF) Expanded Hereditary Cancer Panel, Germline Testing
Participants with Pancreatic Neuroendocrine Neoplasms

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All participants receiving care at University of California participating locations with a new or existing diagnosis of PanNEN

You may qualify if:

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

You may not qualify if:

  • Inability to provide informed consent.
  • For participants who have not had prior testing with a dedicated germline pane of at least 80 genes:
  • 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).
  • Active hematologic malignancy.
  • History of allogenic bone marrow transplant or stem cell transplant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Univeristy of California, San Diego

San Diego, California, 92093, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples will be obtained from participants

MeSH Terms

Conditions

Adenoma, Islet Cell

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Emily Bergsland, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bryan Le

CONTACT

(415) 502-6313bryankhuong.le@ucsf.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2023

First Posted

February 27, 2023

Study Start

April 7, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(3)