Study Results
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.
RECRUITING
250 participants
OBSERVATIONAL
2022-01-20
2032-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Preliminary Evaluation of Screening for Pancreatic Cancer in Patients with Inherited Genetic Risk
NCT02478892
Pancreatic Adenocarcinoma Gene Environment Risk Study
NCT00912717
Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals
NCT06122896
Panc CA Risk Model & Biomarker Testing In High-Risk Cohort
NCT05287347
Study of [68Ga]FAPI-46 PET in Patients With Pancreatic Ductal Carcinoma
NCT05262855
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To determine the event rate of abnormal magnetic resonance imaging (MRI) and Endoscopic ultrasound (EUS) findings in screened study participants.
SECONDARY OBJECTIVES:
I. 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:
I. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Biospecimen Collection
Undergo blood, tissue, and saliva collection
Magnetic Resonance Cholangiopancreatography
Undergo MRCP
Magnetic Resonance Imaging
Undergo MRI
Endoscopic ultrasound
Undergo endoscopic ultrasound
Questionnaires
Complete the following questionnaires: Pancreatic Cancer Knowledge Survey, Pancreatic Cancer Worry Scale, Disease Specific Perceived Risk Survey, eGene Questionnaire
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.
Biospecimen Collection
Undergo blood, tissue, and saliva collection
Magnetic Resonance Cholangiopancreatography
Undergo MRCP
Magnetic Resonance Imaging
Undergo MRI
Endoscopic ultrasound
Undergo endoscopic ultrasound
Questionnaires
Complete the following questionnaires: Pancreatic Cancer Knowledge Survey, Pancreatic Cancer Worry Scale, Disease Specific Perceived Risk Survey, eGene Questionnaire
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Biospecimen Collection
Undergo blood, tissue, and saliva collection
Magnetic Resonance Cholangiopancreatography
Undergo MRCP
Magnetic Resonance Imaging
Undergo MRI
Endoscopic ultrasound
Undergo endoscopic ultrasound
Questionnaires
Complete the following questionnaires: Pancreatic Cancer Knowledge Survey, Pancreatic Cancer Worry Scale, Disease Specific Perceived Risk Survey, eGene Questionnaire
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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:
* 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)
Exclusion Criteria
* Pregnant women are excluded from this study because effects of an MRI on developing fetus is unknown.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, San Francisco
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pamela N Munster, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California San Francisco
San Francisco, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2021-07922
Identifier Type: REGISTRY
Identifier Source: secondary_id
209514
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.