Pilot Study of Pancreatic Cancer Screening

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Carcinoma
• Intervention / Treatment: Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Cholangiopancreatography; Other: Questionnaires; Procedure: Endoscopic ultrasound

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Phu Lam; Phone Number: (415) 353-8337; Email: Phu.Lam@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California San Francisco
      • Contact: Phone Number: 877-827-3222; Email: cancertrials@ucsf.edu
      • Contact: Phu Lam; Phone Number: 415-353-8337; Email: Phu.Lam@ucsf.edu
      • Principal Investigator: Pamela N Munster, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Magnetic Resonance Imaging; Undergo MRI; Other Names: MRI; Magnetic Resonance Imaging Scan; MR Imaging; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Undergo blood, tissue, and saliva collection; Other Names: Biological Sample Collection; Procedure: Magnetic Resonance Cholangiopancreatography; Undergo MRCP; Other Names: MRCP; Other: Questionnaires; Complete the following questionnaires: Pancreatic Cancer Knowledge Survey, Pancreatic Cancer Worry Scale, Disease Specific Perceived Risk Survey, eGene Questionnaire; Other Names: Surveys; Procedure: Endoscopic ultrasound; Undergo endoscopic ultrasound; Other Names: EUS
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.	Procedure: Magnetic Resonance Imaging; Undergo MRI; Other Names: MRI; Magnetic Resonance Imaging Scan; MR Imaging; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Undergo blood, tissue, and saliva collection; Other Names: Biological Sample Collection; Procedure: Magnetic Resonance Cholangiopancreatography; Undergo MRCP; Other Names: MRCP; Other: Questionnaires; Complete the following questionnaires: Pancreatic Cancer Knowledge Survey, Pancreatic Cancer Worry Scale, Disease Specific Perceived Risk Survey, eGene Questionnaire; Other Names: Surveys; Procedure: Endoscopic ultrasound; Undergo endoscopic ultrasound; Other Names: EUS

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores on the Pancreatic Cancer Knowledge Survey	The Pancreatic Cancer Knowledge Survey is a 3-item, multiple choice questionnaire designed to gauge participant knowledge on the risk for pancreatic cancer in patients with inherited cancer risk mutations, specifically pancreatic ductal adenocarcinoma (PDAC) and given to participants at time of enrollment. Scores range from 0 to 3, with a higher score indicating a greater knowledge of general pancreatic cancer information.	Baseline, approximately 1 day
Change in scores on the Pancreatic Cancer Worry Scale	The Pancreatic Cancer Worry Scale is a 4-item, multiple choice questionnaire which assesses the participants level of worry about developing or existing pancreatic cancers. Scores for each item range from 1='rarely or never'/'not at all' to 4="All of the time / very concerned" for a total score range of 4-16. Higher scores indicate a greater level of worry.	Up to 10 years
Change in scores on the Disease Specified Perceived Risk Survey	The Disease Specified Perceived Risk Survey is a 4-item survey which addresses participant's perceived risk of developing cancer. Scores for each item range from 0 to 100, for a total score range of 0-400. Higher scores indicating a greater level of perceived risk.	Up to 10 years

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Pamela N Munster, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Estimated): January 31, 2032
• Study Completion (Estimated): January 31, 2032

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 209514; NCI-2021-07922 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No