Recruiting
Early Phase 1

Observational Study

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT06122896

Conditions

Pancreatic Cancer

Pancreatic Ductal Adenocarcinoma

PDAC

PDAC - Pancreatic Ductal Adenocarcinoma

Pancreatic Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Screening Blood Tests

Endoscopic Ultrasound

Magnetic Resonance Imaging

Magnetic Resonance Cholangiopancreatography

Study Details

Brief 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.

Conditions

Pancreatic Cancer

Pancreatic Ductal Adenocarcinoma

PDAC

PDAC - Pancreatic Ductal Adenocarcinoma

Pancreatic Neoplasm

Study ID

NCT06122896

Start date

Nov 21, 2023

Status verified date

May, 2026

Completion date

Oct 31, 2041

Anticipated

Primary completion date

Oct 31, 2040

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

5000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Pancreatic Cancer High-Risk Participants

Study procedures will be conducted as follows:

  • Baseline visit with questionnaires, blood tests, and pancreas screening procedure (EUS or MRI/MRCP).
  • Pancreas screening procedures (Endoscopic ultrasound (EUS), or Magnetic Resonance (MRI)/Magnetic Resonance Cholangiopancreatography (MRCP), and collection of blood, stool, and saliva samples) every 12 months.
  • Blood tests and questionnaires every 6 months.
  • Follow up visits.

Interventions

Screening Blood Tests

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

Endoscopic Ultrasound

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

Magnetic Resonance Imaging

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

Magnetic Resonance Cholangiopancreatography

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

Primary outcome measure

  • Number of Incident Pancreatic Cancers or High-Grade Pancreatic Neoplasms [ Time Frame: 6-monthly for 3 years with 5-year follow-up ]
  • Number of Imaging-Positive Pancreatic Cancers or High-Grade Neoplasms [ Time Frame: 6-monthly for 3 years with 5-year follow-up ]
  • Number of Imaging-Negative, Assay-Positive Pancreatic Cancers or High-Grade Neoplasms [ Time Frame: 6-monthly for 3 years with 5-year follow-up ]

Central Contacts and Locations

Central contacts

Matthew Yurgelun, MD

617-582-8673matthew_yurgelun@dfci.harvard.edu

Locations

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Matthew Yurgelun, MD

617-582-8673matthew_yurgelun@dfci.harvard.edu

Principal Investigator:

Matthew B Yurgelun, MD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-05-29.