NCT06122896 Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals
| NCT ID | NCT06122896 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Dana-Farber Cancer Institute |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2023-11-21 |
| Primary Completion | 2040-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 5,000 participants in total. It began in 2023-11-21 with a primary completion date of 2040-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Matthew Yurgelun, MD
PRINCIPAL INVESTIGATOR
Dana-Farber Cancer Institute
Frequently Asked Questions
Who can join the NCT06122896 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06122896 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06122896 currently recruiting?
Yes, NCT06122896 is actively recruiting participants. Contact the research team at matthew_yurgelun@dfci.harvard.edu for enrollment information.
Where is the NCT06122896 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States.
Who is sponsoring the NCT06122896 clinical trial?
NCT06122896 is sponsored by Dana-Farber Cancer Institute. The principal investigator is Matthew Yurgelun, MD at Dana-Farber Cancer Institute. The trial plans to enroll 5,000 participants.
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