Pancreatic Neuroendocrine NeoplasmPanNENNCT05746182
Genetic Predisposition Testing Program for Pancreatic Neuroendocrine Neoplasms
An observational study of Pancreatic Neuroendocrine Neoplasm, run by University of California, San Francisco at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neuroendocrine Neoplasm
- What is being tested?
- Hereditary Cancer Panel
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Apr 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All participants receiving care at University of California participating locations with a new or existing diagnosis of PanNEN
Who may be able to join
- Histologically confirmed PanNEN.
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Randy Hecht, MD
- Recruiting
Univeristy of California, San Diego
San Diego, California, 92093
Paul Fanta, MD
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Bryan Le, 415-502-6313, bryankhuong.le@ucsf.edu
877-827-3222, cancertrials@ucsf.edu
About this study
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)
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the frequency of germline mutations in patients with PanNEN.
SECONDARY OBJECTIVES:
- 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:
- 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
- Pancreatic Neuroendocrine Neoplasm
- Being tested
- Hereditary Cancer Panel
- Keywords
- Genetic Assay, Biomarkers
- Medical subject headings
- Adenoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hereditary Cancer PanelDiagnostic test
Also called University of California, San Francisco's (UCSF) Expanded Hereditary Cancer Panel, Germline Testing
UCSF's Internal Clinical Laboratory Improvement Amendments of 1988 (CLIA)-certified Expanded Hereditary Cancer Panel will be employed which measures a minimum 88 genes
| Study group | Role | What they receive |
|---|---|---|
| Participants with Pancreatic Neuroendocrine Neoplasms | Not described Receives: Diagnostic Test: Hereditary Cancer Panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 2 years
Secondary outcomes (4)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start7 Apr 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Neuroendocrine NeoplasmStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of California Pancreatic Cancer Consortium (UCPCC)
- Responsible party
- Sponsor
- Investigators
- Emily Bergsland, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746182
- Sponsor's protocol ID
- 224513
- Other IDs
- NCI-2023-01566
- Acronym
- PanNEN
- Status last verified
- Jan 2026
- First submitted
- 17 Feb 2023
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Predisposition Testing Program for Pancreatic Neuroendocrine Neoplasms
- ClinicalTrials.gov ID
- NCT05746182
- Acronym / sponsor ID
- PanNEN / 224513
- Conditions
- Pancreatic Neuroendocrine Neoplasm
- Keywords
- Genetic Assay, Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of California Pancreatic Cancer Consortium (UCPCC)
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the frequency of germline mutations in patients with PanNEN.
SECONDARY OBJECTIVES:
- 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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Pancreatic Neuroendocrine Neoplasms | – | Diagnostic Test: Hereditary Cancer Panel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All participants receiving care at University of California participating locations with a new or existing diagnosis of PanNEN
Key inclusion criteria (4 listed)
- Histologically confirmed PanNEN.
- 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.
Key exclusion criteria (5 listed)
- Inability to provide informed consent.
- For participants who have not had prior testing with a dedicated germline pane of at least 80 genes:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hereditary Cancer PanelAlso: University of California, San Francisco's (UCSF) Expanded Hereditary Cancer Panel, Germline TestingUCSF's Internal Clinical Laboratory Improvement Amendments of 1988 (CLIA)-certified Expanded Hereditary Cancer Panel will be employed which measures a minimum 88 genes | Diagnostic test | Participants with Pancreatic Neuroendocrine Neoplasms |
Primary outcome
Rate of overall pathogenic germline mutations
Time frame: Up to 2 years
The overall percentage of participants with pathogenic, or likely pathogenic germline mutations will be reported with 95% confidence intervals
4 secondary outcomes
Rates of different types of pathogenic mutations
Time frame: Up to 2 years
Rates of different types of variants of uncertain significance (VUS)
Time frame: Up to 2 years
Rate of declination for participants offered testing.
Time frame: Up to 2 years
Rate of completion of testing
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Bergsland, MD principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neuroendocrine Neoplasm, run by University of California, San Francisco at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bryan Le ((415) 502-6313, bryankhuong.le@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of overall pathogenic germline mutations (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.