Screening for pancreatic cancer in high-risk individuals

Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals

This study is testing if combining blood tests and symptom checks with regular screenings can help find pancreatic cancer earlier in people who are at higher risk because of their genetics.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 5000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Dana-Farber Cancer Institute (Academic / other)
• Locations: 2 sites (Boston, Massachusetts and 1 other locations)
• Trial ID: NCT06122896 on ClinicalTrials.gov

What this trial studies

This research aims to enhance early detection of pancreatic cancer by integrating blood-based tests and symptom reviews with standard screening methods like Endoscopic Ultrasound (EUS) and Magnetic Resonance Imaging (MRI). Participants will undergo a series of screenings, including questionnaires and sample collections, over a period ranging from 30 months to 20 years. The study will involve approximately 5,000 individuals who are at increased risk due to genetic factors. The goal is to determine if this combined approach can identify pancreatic cancer at an earlier stage than current methods.

Who should consider this trial

Good fit: Ideal candidates include individuals with specific genetic variants associated with pancreatic cancer and a family history of the disease.

Not a fit: Patients without the identified genetic risk factors or family history of pancreatic cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier diagnosis and improved outcomes for patients at high risk for pancreatic cancer.

How similar studies have performed: Other studies have shown promise in early detection of pancreatic cancer using similar screening approaches, indicating potential for success in this novel methodology.

Eligibility criteria

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.

Where this trial is running

Boston, Massachusetts and 1 other locations

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

Study contacts

• Principal investigator: Matthew Yurgelun, MD — Dana-Farber Cancer Institute
• Study coordinator: Matthew Yurgelun, MD

Conditions Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma; PDAC; PDAC - Pancreatic Ductal Adenocarcinoma; Pancreatic Neoplasm