RecruitingNCT06271291
Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts
Sponsor
Mayo Clinic
Enrollment
30,000 participants
Start Date
Dec 12, 2024
Study Type
OBSERVATIONAL
Conditions
Summary
This study evaluates individuals without pancreatic cancer, but who have been determined to be at higher-than-average lifetime risk of developing pancreatic cancer to help detect pancreatic cancer or other cancers at an earlier time when they might be more easily treated and cured.
Eligibility
Min Age: 18 Years
Inclusion Criteria25
- PDAC FAMILY HISTORY OR PDAC RELATED GENETIC MUTATIONS:
- Age: 50 or older, plus at least one of the following:
- Mutation unknown or absent:
- + relatives with PDAC on same side of family where 2 affected are first degree related to each other and at least 1 affected is first degree related to subject;
- OR 2+ affected first degree relatives \[(FDR), defined as blood related parents, siblings, or children\]
- Known pathogenic/likely pathogenic (P/LP) mutation in at least one of the following:
- CDKN2A/p16, Peutz-Jeghers syndrome (PJS) serine/threonine kinase 11 (STK11), Hereditary pancreatitis with confirmed protease serine 1 (PRSS1)
- OR 1+ or second degree relative (SDR) with PDAC and a known P/LP mutation in one or more of:
- ATM, BRCA1, BRCA2, PALB2, Lynch syndrome (MLH1, MSH2, MSH6, PMS2, EPCAM), TP53
- HIGH-RISK OR WORRISOME PANCREATIC CYSTS:
- years of age or greater and meeting Fukuoka worrisome (FW) or Fukuoka high-risk (FHR) criteria
- High risk stigmata:
- Obstructive Jaundice in a patient with cystic lesion of the head of the pancreas
- Enhancing mural nodule ≥ 5 mm
- Main pancreatic duct ≥ 10 mm
- Worrisome features:
- Presence of pancreatic duct stricture, defined as focal pancreatic duct narrowing with upstream duct =\> 6 mm
- Cyst ≥ 3 cm
- Enhancing mural nodule \< 5 mm
- Thickened/Enhancing cyst wall
- Main duct size 5-9 mm
- Pancreatitis
- Lymphadenopathy
- Increased CA 19-9
- Cyst growth rate ≥ 5 mm /2 years
Exclusion Criteria5
- Is unable to provide informed consent
- Has received a non-autologous bone marrow transplant or has an active hematologic malignancy (i.e., leukemia or lymphoma)
- Current or prior history of PDAC or total pancreatectomy
- Is currently a prison inmate
- Is not able to speak or read English
Interventions
OTHERNon-Interventional Study
Non-interventional study
Locations(7)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06271291
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