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NCT06271291 | RECRUITING | Pancreatic Carcinoma

Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts
Sponsor:

Mayo Clinic

Brief 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.

Condition or disease

Pancreatic Carcinoma

Intervention/treatment

Non-Interventional Study

Detailed Description:

PRIMARY OBJECTIVES: I. To develop a cohort (biobank of biospecimens and data) of subjects without pancreatic cancer who are at highrisk for pancreatic cancer due to: a strong family history, a mutation in a known pancreatic cancer predisposition gene, or fukuoka worrisome or high-risk pancreatic cysts. II. To follow the cohort subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes. III. To make biospecimen available to PCDC-approved projects to validate potential biomarkers for performance using nested case-control prospective designs. OUTLINE: This is an observational study. Participants undergo blood sample collection, complete questionnaires, have their medical records reviewed and undergo pancreatic cyst fluid collection during standard of care endoscopic ultrasounds fine needle aspiration.

Study Type : OBSERVATIONAL
Estimated Enrollment : 30000 participants
Official Title : Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts
Actual Study Start Date : 2024-12-12
Estimated Primary Completion Date : 2029-11-01
Estimated Study Completion Date : 2029-11-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * PDAC FAMILY HISTORY OR PDAC RELATED GENETIC MUTATIONS
    • * Age: 50 or older, plus at least one of the following
      • * Mutation unknown or absent
        • * 2+ 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, PJS (STK11), Hereditary pancreatitis with confirmed protease serine 1 (PRSS1)
          • * OR 1+FDR 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
              • * 18 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 Criteria
                  • * \* 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
Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts

Location Details

NCT06271291

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

NOT YET RECRUITING

United States, Pennsylvania

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15232