Detecting pancreatic cancer in high-risk individuals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting
• Piedmont Healthcare
  Atlanta, Georgia, United States Recruiting
• OSF Saint Francis Medical Center
  Peoria, Illinois, United States Recruiting
• The Johns Hopkins University School of Medicine
  Baltimore, Maryland, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Ann L. Oberg, PhD — Mayo Clinic in Rochester
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.