Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts

Study Overview

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.

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.

Pancreatic Carcinoma

OTHER: Non-Interventional Study

23-000161
NCI-2024-00504 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trial Reporting Program))
23-000161 (OTHER Identifier) (OTHER: Mayo Clinic in Rochester)
U01CA210138 (U.S. NIH Grant/Contract)
U24CA274496 (U.S. NIH Grant/Contract)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-02-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-01-28
First Submitted that Met QC Criteria 2024-02-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-01-30
First Posted (ACTUAL) 2024-02-21	Results First Posted N/A	Last Verified 2025-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: 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.	OTHER: Non-Interventional Study Non-interventional study

Participant Group/Arm

Intervention/Treatment

: 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.

OTHER: Non-Interventional Study

Non-interventional study

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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Clinical Trials Referral Office

Phone Number: 855-776-0015

Email: mayocliniccancerstudies@mayo.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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, PJS (STK11), Hereditary pancreatitis with confirmed protease serine 1 (PRSS1)
OR 1+FDR 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

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: Ann L. Oberg, PhD, Mayo Clinic in Rochester

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record