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Pancreatic Cancer Screening for At-risk Individuals

This study is looking at how well screening methods work for people at higher risk of pancreatic cancer. It's an observational study, meaning researchers will collect information from people already undergoing screening, rather than assigning them to a treatment. The screening methods used will be EUS (endoscopic ultrasound, a procedure using a thin, flexible tube with a camera and ultrasound probe to look at organs) or MRI (magnetic resonance imaging, a scan that uses magnets and radio waves to create detailed images of organs and tissues). Researchers want to find out how many people undergoing screening are found to have high-risk pancreatic lesions (abnormal areas) that can be treated. You might be able to join if you are between 18 and 90 years old and meet certain guidelines for pancreatic cancer screening, or if your doctor decides you should be screened at a participating center. The study aims to enroll about 1395 participants.

Study design
This is an observational study, meaning researchers will gather information from participants who are already undergoing pancreatic cancer screening. It aims to include about 1395 individuals.
What's involved
Information about your characteristics, findings from your screening examinations, and your health outcomes will be collected. This will be done according to standard medical care.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 5 years, until 2032, to track the proportion of high-risk lesions found and other outcomes.

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NCT05006131

Pancreatic Cancer Screening for At-risk Individuals

Recruiting
Not specifiedAges 18–90Observational
Beth Israel Deaconess Medical Center
~1,395 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:Screening for pancreatic cancer

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of screening patients found to have high-risk pancreatic lesions amenable to treatment
Measured over From year 1 to year 12 (until the end of at least 5 years follow up in 2032), according to the standard of care designated by GI team.

Conditions

Pancreatic Cancer, Adult

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Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Mandeep Sawhney, MD,MS,FASGE · PRINCIPAL_INVESTIGATOR · BIDMC-Harvard Medical School

Who to contact

Roya Dastjerdi, MPH
[email protected]
617-667-4046
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

BRCA1 mutation and at least one affected first-degree relative with pancreatic cancer
BRCA 2 mutation and at least one affected first-degree relative, or at least two relatives of any degree with pancreatic cancer
PALB2 mutation and at least one affected first-degree relative with pancreatic cancer Screening is usually initiated at age 45 or 10 years younger than the youngest family member with pancreatic cancer; or per updated national screening guidelines 2. Lynch syndrome or Ataxia Telangiectasia Mutated (ATM) mutations with at least one affected first-degree relative (FDR). Lynch syndrome could be diagnosed either by using clinical criteria or Mutator L homolog 1 (MLH1), Mutator S homolog 2 (MSH2), Mutator S homolog 6 (MSH6), Postmeiotic Segregation Increased, S. Cerevisiae, 2 (PMS2) or EPCAM mutation.

Exclusion

Patients presenting with symptoms suggestive of pancreatic cancer who are undergoing diagnostic EUS or MRCP e.g. acute recurrent pancreatitis, abnormal imaging

What this trial measures

  • Proportion of screening patients found to have high-risk pancreatic lesions amenable to treatmentFrom year 1 to year 12 (until the end of at least 5 years follow up in 2032), according to the standard of care designated by GI team.

    Proportion of patients who meet CAPS 3 or updated national screening guidelines criteria who are found at screening to have high-risk pancreatic lesions amenable to treatment. These are defined as the following: 1. Lesions with high-grade dysplasia (HGD) 2. High-grade pancreatic intraepithelial neoplasia (PanIN) 3. Resectable or borderline resectable pancreatic cancer. Pancreatic cancers that were staged T1-3, N0-2, and M0 designated as resectable or borderline resectable. Cancers that were staged as T4 or M1 were considered locally advanced or metastatic and therefore designated as unresectable 4. Main duct intra-ductal papillary mucinous neoplasm (IPMN).This will be defined per Fukuoko guidelines as dilation of main pancreatic duct ≥ 5 mm, after duct dilation due to other causes have been excluded. 5. Branch-duct IPMN with "worrisome features". 6. Neuroendocrine tumor ≥ 2 cm.