Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts

Recruiting

• Conditions: Pancreatic Carcinoma
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06271291
• Lead 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.

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 Timeline

• Study First Submitted: 2024-02-14
• Study First Submitted QC: 2024-02-14
• Study First Posted: 2024-02-21
• Study Start: 2024-12-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Primary Completion: 2029-11-01
• Study Completion: 2029-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional 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.

Primary Outcome Measures

Name	Time	Method
Follow subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes	Up to study completion, as defined in description	Participants will be followed until study completion, defined as when one or more of the following occur: * Subject has provided a pre-treatment biospecimen after diagnosis with pancreatic ductal adenocarcinoma (PDAC) or it has been determined that collection of a pre-treatment biospecimen sample after PDAC diagnosis is infeasible.; * Enrollment cyst determined to not be mucinous and thus not worthy of ongoing surveillance.; * Subject has had a complete pancreatectomy.; * Subject has died.; * Study funding has ended
Develop a biobank of biospecimens and data of subjects without pancreatic cancer who are at high risk for pancreatic cancer	Baseline (at enrollment)	Assessed by the number of specimens collected for subjects at right risk 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.

Trial Locations

Locations (2)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States