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RecruitingInterventionalEarly Phase 1

Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals

NCT ID: NCT06122896Sponsor: Dana-Farber Cancer InstituteLast updated: 2026-05-29

Summary

The purpose of this research is to see if adding blood-based tests and symptom review to standard-of-care pancreatic cancer screening procedures can identify cancer early among individuals with increased risk.

Detailed description

In this research study, investigators will combine blood-based tests and review of symptoms with standard-of-care pancreatic cancer screening procedures to see if pancreatic cancer can be detected early among individuals with increased risk. Pancreatic cancer screening procedures include Endoscopic Ultrasound (EUS), Magnetic Resonance Imaging (MRI), or Magnetic Resonance Cholangiopancreatography (MRCP). The research study procedures include screening for eligibility, questionnaires, clinic visits, endoscopic ultrasound (EUS) or Magnetic Resonance (MRI)/Magnetic Resonance Cholangiopancreatography (MRCP), and collection of blood, stool, and saliva samples. Participation in this research study will be a minimum of 30 months and up to 20 years via review of medical records and the annual collection of blood and stool samples. It is expected that about 5,000 people will take part in this research study. This study is supported by the Hale Family Research Center at Dana-Farber Cancer Institute.

Arms & interventions

  • OtherScreening Blood Tests

    Carbohydrate antigen (CA) 19-9, and Hemoglobin A1C (HbA1c) per standard-of-care.

  • Diagnostic TestEndoscopic Ultrasound

    Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.

  • Combination ProductMagnetic Resonance Imaging

    Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.

  • Combination ProductMagnetic Resonance Cholangiopancreatography

    Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.

Outcome measures

Primary

  • Number of Incident Pancreatic Cancers or High-Grade Pancreatic Neoplasms

    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.

    Time frame: 6-monthly for 3 years with 5-year follow-up

  • Number of Imaging-Positive Pancreatic Cancers or High-Grade Neoplasms

    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.

    Time frame: 6-monthly for 3 years with 5-year follow-up

  • Number of Imaging-Negative, Assay-Positive Pancreatic Cancers or High-Grade Neoplasms

    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.

    Time frame: 6-monthly for 3 years with 5-year follow-up

Secondary

  • Positive Predictive Value of Blood Assays

    Time frame: 6-monthly for 3 years

  • Negative Predictive Value of Blood Assays

    Time frame: 6-monthly for 3 years

  • Proportion of Screen-Detected, Resected Pancreatic Lesions

    Time frame: 6-monthly for 3 years

  • Proportion of Non-Worrisome Pancreatic Lesions

    Time frame: 6-monthly for 3 years

  • Incremental Yield of Blood-Based Assays over Standard-of-Care Screening

    Time frame: 6-monthly for 3 years

  • Number of False-Positive Assay Results

    Time frame: 6-monthly for 3 years

  • Number of Non-PDAC Cancer Diagnoses

    Time frame: 6-monthly for 3 years

  • Clinical Predictors of Neoplastic Development

    Time frame: up to 8 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: Yes
Inclusion Criteria: Participants must meet any of the following: * 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 • Exocrine pancreatic cancer in ≥1 first- or second-degree relative from the same side of (or presumed to be from the same side of) the family as the identified pathogenic/likely pathogenic germline variant. * 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 Criteria: * 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.

Study locations (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02215

Not Yet Recruiting
Matthew Yurgelun, MD · Contact
Matthew Yurgelun, MD · Principal Investigator

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting
Matthew Yurgelun, MD · Contact
Matthew B Yurgelun, MD · Principal Investigator
Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals | Cancerify