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Screening for Pancreatic Cancer in High-Risk Individuals

This study is looking at ways to find pancreatic cancer early in people who have a higher chance of getting it. Researchers want to see if adding blood tests (like Carbohydrate antigen (CA) 19-9 and Hemoglobin A1C (HbA1c)) and checking symptoms to regular screening methods can help. Regular screening includes imaging tests like Endoscopic Ultrasound (EUS), Magnetic Resonance Imaging (MRI), and Magnetic Resonance Cholangiopancreatography (MRCP). You might be able to join if you have specific genetic changes (in STK11 or CDKN2A) that increase your risk for pancreatic cancer. The study will measure how many new pancreatic cancers or high-grade (more serious) pancreatic growths are found over time. The study status is unclear, and it plans to enroll about 5,000 people.

Study design
This is an interventional study planning to enroll about 5,000 participants. It combines standard screening with additional blood tests and symptom review.
What's involved
You would have screening for eligibility, fill out questionnaires, attend clinic visits, undergo EUS or MRI/MRCP, and provide blood, stool, and saliva samples. Participation will last a minimum of 30 months and up to 20 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years after the initial 3-year measurement period for incident pancreatic cancers or high-grade neoplasms.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06122896

Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals

Recruiting
EARLY_PHASE1Ages 18+InterventionalScreening
Dana-Farber Cancer Institute
~5,000 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:Screening Blood TestsEndoscopic UltrasoundMagnetic Resonance ImagingMagnetic Resonance Cholangiopancreatography

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Incident Pancreatic Cancers or High-Grade Pancreatic Neoplasms
Measured over 6-monthly for 3 years with 5-year follow-up
+2 more outcomes measured

Conditions

Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
PDAC
PDAC - Pancreatic Ductal Adenocarcinoma
Pancreatic Neoplasm

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Where it's being run

2 sites across 1 states
Massachusetts2

Study leadership

  • Matthew Yurgelun, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

Matthew Yurgelun, MD
[email protected]
617-582-8673
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Individuals with pathogenic/likely pathogenic germline variants in STK11, and age ≥30 years.
Individuals with pathogenic/likely pathogenic germline variants in CDKN2A, and age ≥40 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier).
Individuals with pathogenic/likely pathogenic germline variants in one of the other pancreatic cancer susceptibility genes (ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, EPCAM, PALB2, TP53), and age ≥50 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier) AND
Individuals with pathogenic/likely pathogenic variants in PRSS1 AND a clinical phenotype consistent with hereditary pancreatitis, and age ≥40 years (or 20 years after onset of pancreatitis, whichever is earlier).
Individuals with familial pancreatic cancer including:
Family history of exocrine pancreatic cancer in ≥2 first-degree relatives from the same side of the family, even in the absence of a known pathogenic/likely pathogenic germline variant, OR
Family history of exocrine pancreatic cancer in 1 affected first-degree relative and 1 second-degree relative, even in the absence of a known pathogenic/likely pathogenic germline variant, OR
Family history of exocrine pancreatic cancer in ≥3 first- and/or second-degree relatives from the same side of the family, even in the absence of a known pathogenic/likely pathogenic germline variant.
Individuals who are undergoing clinically recommended pancreatic cancer surveillance.

Exclusion

Individuals with active or prior pancreatic ductal adenocarcinoma diagnosis.
Individuals with any active metastatic cancer.
Individuals who are unable to give informed consent.
Individuals who are under the age of 18 (infants, children, teenagers).
Individuals unable to tolerate Magnetic Resonance Imaging/Magnetic Resonance Cholangiopancreatography and Endoscopic Ultrasound.
Pregnant women are unlikely to be undergoing screening procedures and will not be considered eligible but can consent to the study at a later date.

What this trial measures

  • Number of Incident Pancreatic Cancers or High-Grade Pancreatic Neoplasms6-monthly for 3 years with 5-year follow-up

    Subjects will be counted in this metric if they have pathological tissue confirmation of a pancreatic cancer or high-grade dysplasia during each observation period.

  • Number of Imaging-Positive Pancreatic Cancers or High-Grade Neoplasms6-monthly for 3 years with 5-year follow-up

    Subjects will be considered imaging-positive if they have a biopsy-confirmed pancreatic ductal adenocarcinoma or high-grade dysplasia that was initially detected on standard-of-care screening MRI or EUS during each observation period.

  • Number of Imaging-Negative, Assay-Positive Pancreatic Cancers or High-Grade Neoplasms6-monthly for 3 years with 5-year follow-up

    Subjects will be considered imaging-negative and assay-positive if: 1) the subject has a study visit that yields any newly positive CA19-9 (\>35U/mL or \>=20% increase) or diabetes (FBG \>100mg/dL for first time or HgbA1c increased by 0.5) assay result or ENDPAC score \>=3 with negative MRI and/or EUS at that visit or within six months prior to that visit; and 2) has a biopsy-confirmed pancreatic ductal adenocarcinoma or high-grade dysplasia within two years after that visit.