Detecting pancreatic cancer in high-risk individuals

Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts

This study is trying to find better ways to detect pancreatic cancer early in people who are at high risk due to family history or genetic factors.

Quick facts

• Study type: Observational
• Enrollment: 30000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mayo Clinic (Academic / other)
• Locations: 7 sites (Scottsdale, Arizona and 6 other locations)
• Trial ID: NCT06271291 on ClinicalTrials.gov

What this trial studies

This observational study aims to create a cohort of individuals without pancreatic cancer who are at an elevated lifetime risk due to factors such as strong family history, genetic mutations, or high-risk pancreatic cysts. Participants will undergo blood sample collection, complete questionnaires, and have their medical records reviewed, along with pancreatic cyst fluid collection during standard care procedures. The study will follow these individuals over time to gather biospecimens and medical outcomes, which will be used to validate potential biomarkers for early cancer detection.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 50 or older with a strong family history of pancreatic cancer or known genetic mutations associated with the disease.

Not a fit: Patients without a family history of pancreatic cancer or those who do not meet the high-risk criteria will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier detection of pancreatic cancer, improving treatment outcomes and survival rates.

How similar studies have performed: Other studies focusing on high-risk populations for pancreatic cancer have shown promise in early detection strategies, suggesting this approach may be effective.

Eligibility 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, 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:

  * 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

Where this trial is running

Scottsdale, Arizona and 6 other locations

• HonorHealth Research Institute — Scottsdale, Arizona, United States (Withdrawn)
• Piedmont Healthcare — Atlanta, Georgia, United States (Recruiting)
• OSF Saint Francis Medical Center — Peoria, Illinois, United States (Recruiting)
• Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
• Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Ann L. Oberg, PhD — Mayo Clinic in Rochester
• Study coordinator: Clinical Trials Referral Office

Conditions Pancreatic Carcinoma