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Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts

This observational study, called the Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts, is for people who do not have pancreatic cancer but are at a higher risk of developing it. This includes individuals with a strong family history of pancreatic cancer, those with specific gene changes (mutations) like ATM, BRCA1, BRCA2, CDKN2A, PALB2, STK11, or TP53 that increase risk, or those with certain pancreatic cysts. The study aims to create a collection of biological samples (biobank) and health information from these individuals. By following participants over time, researchers hope to find better ways to detect pancreatic cancer or other cancers earlier, when they might be easier to treat. This study is not testing a specific drug or intervention.

Study design
This is an observational study planning to enroll 30,000 participants. It is not testing a specific treatment, but rather collecting information and samples.
What's involved
Participants will provide blood samples, complete questionnaires, have their medical records reviewed, and may have pancreatic cyst fluid collected during routine procedures.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed longitudinally, with data and medical outcomes recorded until the study's completion.

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NCT06271291

Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts

Recruiting
Not specifiedAges 18+Observational
Mayo Clinic
~30,000 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:Non-Interventional Study

At a glance

Recruiting sites
8 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Develop a biobank of biospecimens and data of subjects without pancreatic cancer who are at high risk for pancreatic cancer
Measured over Baseline (at enrollment)
+1 more outcome measured

Conditions

Pancreatic Carcinoma

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Pancreatic CarcinomaATM GeneBRCA1 GeneBRCA2 GeneCDKN2A GeneDNA Mismatch Repair Protein Mlh1EPCAM GeneMSH2 GeneMSH6 GenePartner and Localizer of BRCA2PMS2 GeneSTK11 GeneTP53 GeneTrypsin-1

Where it's being run

9 sites across 9 states
Arizona1
Georgia1
Illinois1
Maryland1
Massachusetts1
Minnesota1
Nebraska1
Oregon1

Study leadership

  • Ann L. Oberg, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Develop a biobank of biospecimens and data of subjects without pancreatic cancer who are at high risk for pancreatic cancerBaseline (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.

  • Follow subjects longitudinally and collect biospecimens and follow-up data and record medical outcomesUp 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