Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05058846

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pancreatic Carcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biospecimen Collection

Procedure

Undergo blood, tissue, and saliva collection

Other names: Biological Sample Collection

Magnetic Resonance Cholangiopancreatography

Procedure

Undergo MRCP

Other names: MRCP

Magnetic Resonance Imaging

Procedure

Undergo MRI

Other names: Magnetic Resonance Imaging Scan, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Endoscopic Ultrasound

Procedure

Undergo endoscopic ultrasound

Other names: EUS

questionnaires

Other

Complete the following questionnaires: Pancreatic Cancer Knowledge Survey, Pancreatic Cancer Worry Scale, Disease Specific Perceived Risk Survey, eGene Questionnaire

Other names: Surveys

Primary outcomes

  1. 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

  1. Overall Cancer Detection Rate

    Time frame: Up to 10 years

    Will estimate and infer 95% binomial confidence intervals (CI) and the overall cancer detection rate for all participants on study.

  2. Rates of high-grade neoplastic precursors

    Time frame: Up to 10 years

    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.

  3. Rates of pancreatic ductal adenocarcinoma (PDAC)

    Time frame: Up to 10 years

    Will estimate and infer 95% binomial CI and the overall rate of PDAC for all participants on study.

  4. Proportion of participants who have additional medical procedures

    Time frame: Up to 10 years

    The proportion of participants who have obtained a biopsy or underwent a surgical procedure related to a possible diagnosis of cancer will be reported.

Other outcomes

  1. Scores on the Pancreatic Cancer Knowledge Survey

    Time frame: Baseline, approximately 1 day

    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.

  2. Change in scores on the Pancreatic Cancer Worry Scale

    Time frame: Up to 10 years

    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.

  3. Change in scores on the Disease Specified Perceived Risk Survey

    Time frame: Up to 10 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Phu Lam

CONTACT

[email protected]

(415) 353-8337

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
Sep 28, 2021
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.