Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals
Recruiting · NCT06122896 · Interventional (participants receive a specific treatment) · Lead sponsor: Dana-Farber Cancer Institute
View the official record on ClinicalTrials.gov →Interventions studied
Endoscopic UltrasoundMagnetic Resonance CholangiopancreatographyMagnetic Resonance ImagingScreening Blood Tests
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
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 it is running
2 locations listed across 1 US state.
- Brigham and Women's Hospital - Boston, Massachusetts, United States
- Dana Farber Cancer Institute - Boston, Massachusetts, United States