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)

HonorHealth Research Institute

Scottsdale, Arizona, United States

Piedmont Healthcare

Atlanta, Georgia, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT06271291


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