RecruitingEarly Phase 1NCT06122896

Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals


Sponsor

Dana-Farber Cancer Institute

Enrollment

5,000 participants

Start Date

Nov 21, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria11

  • 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 Criteria6

  • 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.

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.


Locations(2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

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NCT06122896


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