Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals

Recruiting now · Early Phase 1

Conditions studied: Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, Pancreatic Neoplasm

In brief

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.

Key facts

Study ID

NCT06122896

Run by

Dana-Farber Cancer Institute

People needed

5000

Starts

2023-11-21

Expected to finish

2041-10-31

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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