Pilot Study of Pancreatic Cancer Screening
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Carcinoma
- Sponsor
- University of California, San Francisco
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Proportion of participants with of abnormal magnetic resonance imaging (MRI) findings
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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. This study may lead to a greater understanding of cancer and potentially, improvements in cancer screening and treatment.
Detailed Description
PRIMARY OBJECTIVE: 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Overall Cancer Detection Rate(Up to 10 years)
- Proportion of participants who have additional medical procedures(Up to 10 years)
- Rates of pancreatic ductal adenocarcinoma (PDAC)(Up to 10 years)
- Rates of high-grade neoplastic precursors(Up to 10 years)