NCT05058846

Pilot Study of Pancreatic Cancer Screening

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pancreatic Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood, tissue, and saliva collection
PROCEDURE	Magnetic Resonance Cholangiopancreatography	Undergo MRCP
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Endoscopic ultrasound	Undergo endoscopic ultrasound
OTHER	Questionnaires	Complete the following questionnaires: Pancreatic Cancer Knowledge Survey, Pancreatic Cancer Worry Scale, Disease Specific Perceived Risk Survey, eGene Questionnaire

Timeline

• Start date: 2022-01-20
• Primary completion: 2032-01-31
• Completion: 2032-01-31
• First posted: 2021-09-28
• Last updated: 2025-05-02

Locations

1 site across 1 country: United States