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Trial Title:
Genetic Predisposition Testing Program for Pancreatic Neuroendocrine Neoplasms
NCT ID:
NCT05746182
Condition:
Pancreatic Neuroendocrine Neoplasm
Conditions: Official terms:
Neoplasms
Neuroendocrine Tumors
Adenoma, Islet Cell
Disease Susceptibility
Genetic Predisposition to Disease
Conditions: Keywords:
Genetic Assay
Biomarkers
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Hereditary Cancer Panel
Description:
UCSF's Internal Clinical Laboratory Improvement Amendments of 1988 (CLIA)-certified
Expanded Hereditary Cancer Panel will be employed which measures a minimum 88 genes
Arm group label:
Participants with Pancreatic Neuroendocrine Neoplasms
Other name:
University of California, San Francisco's (UCSF) Expanded Hereditary Cancer Panel
Other name:
Germline Testing
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)
Detailed 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.
Criteria for eligibility:
Study pop:
All participants receiving care at University of California participating locations with
a new or existing diagnosis of PanNEN
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
University of California, Los Angeles
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Randy Hecht, MD
Email:
Principal Investigator
Facility:
Name:
Univeristy of California, San Diego
Address:
City:
San Diego
Zip:
92093
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Paul Fanta, MD
Email:
Principal Investigator
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Paige Steiding
Phone:
415-514-6314
Email:
Paige.Steiding@ucsf.edu
Contact backup:
Phone:
877-827-3222
Email:
cancertrials@ucsf.edu
Investigator:
Last name:
Emily Bergsland, MD
Email:
Principal Investigator
Start date:
April 7, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
University of California, San Francisco
Agency class:
Other
Collaborator:
Agency:
University of California Pancreatic Cancer Consortium (UCPCC)
Agency class:
Other
Source:
University of California, San Francisco
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05746182
