Recruiting

Observational StudyPancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts

Sponsor:

Mayo Clinic

Code:

NCT06271291

Conditions

Pancreatic Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

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.

Conditions

Pancreatic Carcinoma

Study ID

NCT06271291

Start date

Dec 12, 2024

Status verified date

Sep, 2026

Completion date

Nov 1, 2029

Anticipated

Primary completion date

Nov 1, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

30000 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

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.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

Develop a biobank of biospecimens and data of subjects without pancreatic cancer who are at high risk for pancreatic cancer [ Time Frame: Baseline (at enrollment) ]
Follow subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes [ Time Frame: Up to study completion, as defined in description ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Kimberly S. Kirkwood, MD

415-502-0427 kim.kirkwood@ucsf.edu

Piedmont Healthcare

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Meiri Eyal

404-425-1777 eyal.meiri@piedmont.org

Principal Investigator:

Meiri Eyal, MD

OSF Saint Francis Medical Center

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Chandler Wilfong, MD

309-691-4005 chandler.d.wilfong@osfhealthcare.org

Principal Investigator:

Chandler Wilfong, MD

The Johns Hopkins University School of Medicine

Recruiting

Baltimore, Maryland, United States, 21231

Contacts

Michael Goggins, MD

410-955-3511 mgoggins@jhmi.edu

Principal Investigator:

Michael Goggins, MD

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Brian Wolpin, MD, MPH

617-632-6942 brian_wolpin@dfci.harvard.edu

Principal Investigator:

Brian Wolpin, MD, MPH

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

Shounak Majumder, MD

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198-6805

Contacts

Kelsey Klute, MD

402-559-1880 Kelsey.klute@unmc.edu

Principal Investigator:

Kelsey Klute, MD

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97201

Contacts

Rosalie Sears, PhD

503-494-6885 searsr@ohsu.edu

Principal Investigator:

Rosalie Sears, PhD

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Randall Brand, MD

412-864-7516

Principal Investigator:

Randall Brand, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-09-03.