Trial NCT06122896
Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals
- Phase
- Early phase 1
- Sponsor
- Dana-Farber Cancer Institute
- Conditions
- Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma; PDAC; PDAC - Pancreatic Ductal Adenocarcinoma; Pancreatic Neoplasm
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
Participants must meet any of the following:
* Individuals with pathogenic/likely pathogenic germline variants in STK11, and age ≥30 years.Age
* 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.Prior malignancy
* 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.Pregnancy
Restrictions found (3)
- AgeOutrightinclusion
age >= 30
Show in the text - PregnancyConditionalexclusionShow in the text
- Prior malignancyOutrightexclusionShow in the text
Recruiting in Massachusetts
- Dana Farber Cancer Institute · Boston, Suffolk County