Pilot Study of Pancreatic Cancer Screening

Study Overview
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Brief Summary
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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
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PRIMARY OBJECTIVE: I. To determine the event rate of abnormal magnetic resonance imaging (MRI) 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: Participants may opt to undergo MRI/ magnetic resonance cholangiopancreatography (MRCP) annually for 10 years or complete questionnaires over 10 minutes and undergo blood, saliva and tissue sample collection. GROUP II: Participants undergo MRI/MRCP screening annually for 10 years.

Official Title
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Pilot Study of Pancreatic Cancer Screening

Conditions
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Pancreatic Carcinoma

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Procedure: Magnetic Resonance Cholangiopancreatography
* Procedure: Magnetic Resonance Imaging
* Procedure: Endoscopic ultrasound
* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: 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: Prior or active pancreatic cancer. Pregnant women are excluded from this study because effects of an MRI on developing fetus is unknown.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I: No strong family history of pancreatic cancer<br>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) 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. | Procedure: Biospecimen Collection<br>* Undergo blood, tissue, and saliva collection<br>* Other names: Biological Sample Collection;Procedure: Magnetic Resonance Cholangiopancreatography<br>* Undergo MRCP<br>* Other names: MRCP;Procedure: Magnetic Resonance Imaging<br>* Undergo MRI<br>* Other names: Nuclear Magnetic Resonance Imaging;Other: Questionnaires<br>* Complete the following questionnaires: Pancreatic Cancer Knowledge Survey, Pancreatic Cancer Worry Scale, Disease Specific Perceived Risk Survey, eGene Questionnaire<br>* Other names: Surveys;|
| Group II: Strong family history of pancreatic cancer<br>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. | Procedure: Biospecimen Collection<br>* Undergo blood, tissue, and saliva collection<br>* Other names: Biological Sample Collection;Procedure: Magnetic Resonance Cholangiopancreatography<br>* Undergo MRCP<br>* Other names: MRCP;Procedure: Magnetic Resonance Imaging<br>* Undergo MRI<br>* Other names: Nuclear Magnetic Resonance Imaging;Procedure: Endoscopic ultrasound<br>* Undergo endoscopic ultrasound<br>* Other names: EUS;Other: Questionnaires<br>* Complete the following questionnaires: Pancreatic Cancer Knowledge Survey, Pancreatic Cancer Worry Scale, Disease Specific Perceived Risk Survey, eGene Questionnaire<br>* Other names: Surveys;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Cancer Detection Rate | Will estimate and infer 95% binomial confidence intervals (CI) and the overall cancer detection rate for all participants on study. | 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. | 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. | 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. | Up to 10 years |