Pancreatic CarcinomaNCT05058846
Pilot Study of Pancreatic Cancer Screening
An observational study of Pancreatic Carcinoma, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study investigates how often abnormal findings from routine magnetic resonance imaging occur in people with genetic mutations in BReast CAncer gene. (BRCA), ataxia telangiectasia mutated gene (ATM), or PALB2 screened for pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Carcinoma
- What is being tested?
- Biospecimen Collection, Magnetic Resonance Cholangiopancreatography and Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2022to 19 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with germline BRCA, ATM or PALB2 mutation with or without a strong family history of pancreatic cancer. Eligible participants will be identified through UCSF's Hereditary Cancer Clinic or referred through UCSF's gastroenterology clinics.
Who may be able to join
- Ability to provide consent and willing, and able to comply with study procedures Ability to read and speak English
- GROUP I:
- Documentation of pathogenic or likely pathogenic germline BRCA 1 and 2, ATM or PALB2 germline genetic mutation
- No strong family history of pancreatic cancer (defined as having >= 1 first-degree or second-degree relative with a history of pancreatic cancer)
- Age >= 50 years old at time of consent.
- GROUP II:
Show all 9Show fewer
- Documentation of pathogenic or likely pathogenic germline BRCA 1 and 2, ATM, or PALB2 germline genetic mutation
- Has strong family history of pancreatic cancer (defined as having >= 1 first-degree or second-degree relative with a history of pancreatic cancer)
- Age >= 18 years old at time of consent (screening generally begins 10 years prior to the earliest pancreatic cancer in the family)
Who cannot join
- Prior or active pancreatic cancer.
- Pregnant women are excluded from this study because effects of an MRI on developing fetus is unknown.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
This study investigates how often abnormal findings from routine magnetic resonance imaging occur in people with genetic mutations in BReast CAncer gene. (BRCA), ataxia telangiectasia mutated gene (ATM), or PALB2 screened for pancreatic cancer. This study may lead to a greater understanding of cancer and potentially, improvements in cancer screening and treatment.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the event rate of abnormal magnetic resonance imaging (MRI) and Endoscopic ultrasound (EUS) findings in screened study participants.
SECONDARY OBJECTIVES:
- To determine the rates of high-grade pancreatic neoplasia precursors (intraductal papillary mucinous neoplasm (IPMN)-high-grade dysplasia (HGD)) and pancreatic intraepithelial neoplasia-3 [PanIN-3]) and pancreatic ductal adenocarcinoma (PDAC) among all study participants.
II. To understand rates of procedures (biopsies and surgeries) among all study participants.
EXPLORATORY OBJECTIVES:
- To create a biorepository of all participants through the collection of saliva, blood, and tissue, combined with imaging findings and robust clinical annotation of patient health behaviors in all study participants.
II. To explore knowledge, attitudes, and anxiety related to pancreatic cancer screening at annual intervals in all study participants.
OUTLINE: Participants are assigned to 1 of 2 groups.
GROUP I: GROUP I: Participants may opt to undergo MRI/magnetic resonance cholangiopancreatography (MRCP) or alternating MRI/MRCP and EUS annually for 10 years or complete questionnaires over 10 minutes and undergo blood, saliva and tissue sample collection.
GROUP II: Participants may undergo MRI/MRCP or alternating MRI/MRCP and EUS annually for 10 years.
- Conditions
- Pancreatic Carcinoma
- Being tested
- Biospecimen Collection, Magnetic Resonance Cholangiopancreatography, Magnetic Resonance Imaging, Endoscopic ultrasound, Questionnaires
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection
Undergo blood, tissue, and saliva collection
Magnetic Resonance CholangiopancreatographyProcedure or surgery
Also called MRCP
Undergo MRCP
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, MR Imaging, MRI, MRI Scan
Undergo MRI
Endoscopic ultrasoundProcedure or surgery
Also called EUS
Undergo endoscopic ultrasound
QuestionnairesOther
Also called Surveys
Complete the following questionnaires: Pancreatic Cancer Knowledge Survey, Pancreatic Cancer Worry Scale, Disease Specific Perceived Risk Survey, eGene Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Group I: No strong family history of pancreatic cancer | Participants in Group 1 consist of BRCA, ATM and PALB2 mutation carriers without a strong family history of pancreatic cancer and can choose to undergo annual magnetic resonance imaging (MRI)/Magnetic resonance cholangiopancreatography (MRCP) and EUS screening, or they may opt out of annual MRI screening. Participants also have the opportunity to co-enroll in the University of California, San Francisco (UCSF) BRCA Center Biorepository for biospecimen/biomarker collection and will complete surveys, including the optional eGene questionnaire, which involves co-enrollment in the eGene Study. Receives: Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Cholangiopancreatography; Procedure: Magnetic Resonance Imaging; Procedure: Endoscopic ultrasound; Other: Questionnaires | |
| Group II: Strong family history of pancreatic cancer | Participants in Group 2 consist of BRCA, ATM and PALB2 mutation carriers with a strong family history of pancreatic cancer. Participants may undergo annual MRI/MRCP screening and may also elect to get an endoscopic ultrasound (EUS) every other year. Participants also have the opportunity to co-enroll in the UCSF BRCA Center Biorepository for biospecimen/biomarker collection and will complete surveys, including the optional eGene questionnaire, which involves co-enrollment in the eGene Study. Receives: Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Cholangiopancreatography; Procedure: Magnetic Resonance Imaging; Procedure: Endoscopic ultrasound; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with of abnormal magnetic resonance imaging (MRI) findings
Proportion of participants with an abnormal MRI finding will be reported as an event. An estimated event rate of 19% in participants with a strong family history (FH) of pancreatic cancer and 10% in those participants without a strong FH of pancreatic cancer and 95% binomial confidence intervals (CIs) will also be reported.
Measured: Up to 10 years
Secondary outcomes (4)
Overall Cancer Detection Rate
Will estimate and infer 95% binomial confidence intervals (CI) and the overall cancer detection rate for all participants on study.
Measured: Up to 10 years
Rates of high-grade neoplastic precursors
Will estimate and infer 95% binomial CI and the overall rate of high-grade pancreatic neoplasia precursors (IPMN-HGD and PanIN-3) for all participants on study.
Measured: Up to 10 years
Rates of pancreatic ductal adenocarcinoma (PDAC)
Will estimate and infer 95% binomial CI and the overall rate of PDAC for all participants on study.
Measured: Up to 10 years
Proportion of participants who have additional medical procedures
The proportion of participants who have obtained a biopsy or underwent a surgical procedure related to a possible diagnosis of cancer will be reported.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start20 Jan 2022
- Primary completion19 Oct 2026
- Study completion19 Oct 2026
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CarcinomaStudies 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela N Munster, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058846
- Sponsor's protocol ID
- 209514
- Other IDs
- NCI-2021-07922
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2021
- Last updated
- 26 Oct 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 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Pancreatic Cancer Screening
- ClinicalTrials.gov ID
- NCT05058846
- Acronym / sponsor ID
- 209514
- Conditions
- Pancreatic Carcinoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 19 Oct 2026 (actual)
- Study completion
- 19 Oct 2026 (actual)
- First posted
- 28 Sep 2021 (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 study investigates how often abnormal findings from routine magnetic resonance imaging occur in people with genetic mutations in BReast CAncer gene. (BRCA), ataxia telangiectasia mutated gene (ATM), or PALB2 screened for pancreatic cancer. This study may lead to a greater understanding of cancer and potentially, improvements in cancer screening and treatment.
Detailed description
PRIMARY OBJECTIVE:
- To determine the event rate of abnormal magnetic resonance imaging (MRI) and Endoscopic ultrasound (EUS) findings in screened study participants.
SECONDARY OBJECTIVES:
- To determine the rates of high-grade pancreatic neoplasia precursors (intraductal papillary mucinous neoplasm (IPMN)-high-grade dysplasia (HGD)) and pancreatic intraepithelial neoplasia-3 [PanIN-3]) and pancreatic ductal adenocarcinoma (PDAC) among all study participants.
II. To understand rates of procedures (biopsies and surgeries) among all study participants.
EXPLORATORY OBJECTIVES:
- To create a biorepository of all participants through the collection of saliva, blood, and tissue, combined with imaging findings and robust clinical annotation of patient health behaviors in all study participants.
II. To explore knowledge, attitudes, and anxiety related to pancreatic cancer screening at annual intervals in all study participants.
OUTLINE: Participants are assigned to 1 of 2 groups.
GROUP I: GROUP I: Participants may opt to undergo MRI/magnetic resonance cholangiopancreatography (MRCP) or alternating MRI/MRCP and EUS annually for 10 years or complete questionnaires over 10 minutes and undergo blood, saliva and tissue sample collection.
GROUP II: Participants may undergo MRI/MRCP or alternating MRI/MRCP and EUS annually for 10 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I: No strong family history of pancreatic cancer | – | Procedure: Biospecimen Collection, Procedure: Magnetic Resonance Cholangiopancreatography, Procedure: Magnetic Resonance Imaging, Procedure: Endoscopic ultrasound, Other: QuestionnairesParticipants in Group 1 consist of BRCA, ATM and PALB2 mutation carriers without a strong family history of pancreatic cancer and can choose to undergo annual magnetic resonance imaging (MRI)/Magnetic resonance cholangiopancreatography (MRCP) and EUS screening, or they may opt out of annual MRI screening. Participants also have the opportunity to co-enroll in the University of California, San Francisco (UCSF) BRCA Center Biorepository for biospecimen/biomarker collection and will complete surveys, including the optional eGene questionnaire, which involves co-enrollment in the eGene Study. |
| Group II: Strong family history of pancreatic cancer | – | Procedure: Biospecimen Collection, Procedure: Magnetic Resonance Cholangiopancreatography, Procedure: Magnetic Resonance Imaging, Procedure: Endoscopic ultrasound, Other: QuestionnairesParticipants in Group 2 consist of BRCA, ATM and PALB2 mutation carriers with a strong family history of pancreatic cancer. Participants may undergo annual MRI/MRCP screening and may also elect to get an endoscopic ultrasound (EUS) every other year. Participants also have the opportunity to co-enroll in the UCSF BRCA Center Biorepository for biospecimen/biomarker collection and will complete surveys, including the optional eGene questionnaire, which involves co-enrollment in the eGene Study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with germline BRCA, ATM or PALB2 mutation with or without a strong family history of pancreatic cancer. Eligible participants will be identified through UCSF's Hereditary Cancer Clinic or referred through UCSF's gastroenterology clinics.
Key inclusion criteria (9 listed)
- Ability to provide consent and willing, and able to comply with study procedures Ability to read and speak English
- Documentation of pathogenic or likely pathogenic germline BRCA 1 and 2, ATM or PALB2 germline genetic mutation
- No strong family history of pancreatic cancer (defined as having >= 1 first-degree or second-degree relative with a history of pancreatic cancer)
- Age >= 50 years old at time of consent.
- Documentation of pathogenic or likely pathogenic germline BRCA 1 and 2, ATM, or PALB2 germline genetic mutation
Key exclusion criteria (2 listed)
- Prior or active pancreatic cancer.
- Pregnant women are excluded from this study because effects of an MRI on developing fetus is unknown.
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample CollectionUndergo blood, tissue, and saliva collection | Procedure or surgery | Group I: No strong family history of pancreatic cancer, Group II: Strong family history of pancreatic cancer |
| Magnetic Resonance CholangiopancreatographyAlso: MRCPUndergo MRCP | Procedure or surgery | Group I: No strong family history of pancreatic cancer, Group II: Strong family history of pancreatic cancer |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, MR Imaging, MRI, MRI ScanUndergo MRI | Procedure or surgery | Group I: No strong family history of pancreatic cancer, Group II: Strong family history of pancreatic cancer |
| Endoscopic ultrasoundAlso: EUSUndergo endoscopic ultrasound | Procedure or surgery | Group I: No strong family history of pancreatic cancer, Group II: Strong family history of pancreatic cancer |
| QuestionnairesAlso: SurveysComplete the following questionnaires: Pancreatic Cancer Knowledge Survey, Pancreatic Cancer Worry Scale, Disease Specific Perceived Risk Survey, eGene Questionnaire | Other | Group I: No strong family history of pancreatic cancer, Group II: Strong family history of pancreatic cancer |
Primary outcome
Proportion of participants with of abnormal magnetic resonance imaging (MRI) findings
Time frame: Up to 10 years
Proportion of participants with an abnormal MRI finding will be reported as an event. An estimated event rate of 19% in participants with a strong family history (FH) of pancreatic cancer and 10% in those participants without a strong FH of pancreatic cancer and 95% binomial confidence intervals (CIs) will also be reported.
4 secondary outcomes
Overall Cancer Detection Rate
Time frame: Up to 10 years
Rates of high-grade neoplastic precursors
Time frame: Up to 10 years
Rates of pancreatic ductal adenocarcinoma (PDAC)
Time frame: Up to 10 years
Proportion of participants who have additional medical procedures
Time frame: Up to 10 years
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Carcinoma
RecruitingPhase 2
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer
Metastatic Colorectal Cancer, Metastatic Pancreatic Cancer
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
Active, not recruitingPhase 1/2
Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
Locally Advanced Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingPhase 2
APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation
Pancreatic Acinar Cell Carcinoma, Pancreatic Adenosquamous Carcinoma
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. This study is not recruiting at the moment.
Pamela N Munster, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Carcinoma, run by University of California, San Francisco at 1 site 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 9 inclusion and 2 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: stopped early, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with of abnormal magnetic resonance imaging (MRI) findings (time frame: Up to 10 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 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.