RecruitingRecruiting
Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts
NCT06271291 · Mayo Clinic
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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.
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
Study design
Enrollment target: 30000 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-12-12
Estimated completion: 2029-11-01
Last updated: 2026-06-01
Interventions
Other: Non-Interventional Study
Primary outcomes
- • Develop a biobank of biospecimens and data of subjects without pancreatic cancer who are at high risk for pancreatic cancer (Baseline (at enrollment))
- • Follow subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes (Up to study completion, as defined in description)
Sponsor
Mayo Clinic · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactClinical Trials Referral Office · contact · mayocliniccancerstudies@mayo.edu · 855-776-0015
InvestigatorAnn L. Oberg, PhD · principal_investigator, Mayo Clinic in Rochester
All locations (9)
HonorHealth Research InstituteWithdrawn
Scottsdale, Arizona, United States
Piedmont HealthcareRecruiting
Atlanta, Georgia, United States
OSF Saint Francis Medical CenterRecruiting
Peoria, Illinois, United States
The Johns Hopkins University School of MedicineRecruiting
Baltimore, Maryland, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Mayo Clinic in RochesterRecruiting
Rochester, Minnesota, United States
University of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
Oregon Health & Science UniversityRecruiting
Portland, Oregon, United States
University of PittsburghRecruiting
Pittsburgh, Pennsylvania, United States