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Pancreatic CarcinomaNCT06271291

Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts

An observational study of Pancreatic Carcinoma, run by Mayo Clinic at 11 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Carcinoma
What is being tested?
Non-Interventional Study
How many people
30,000 participants
Where
11 sitesUnited States
Study dates
12 Dec 2024to 1 Nov 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with pancreatic ductal adenocarcinoma (PDAC) family history, PDAC related genetic mutations or high risk or worrisome pancreatic cysts

Who may be able to join

  • 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:
Show all 25Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

11 sites in 1 country

United States11 sites, 10 recruiting

  • Piedmont Healthcare

    Atlanta, Georgia, 30309

    Meiri Eyal, MD, 404-425-1777, eyal.meiri@piedmont.org

    Meiri Eyal, MD

    Recruiting

  • The Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21231

    Michael Goggins, MD, 410-955-3511, mgoggins@jhmi.edu

    Michael Goggins, MD

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Brian Wolpin, MD, MPH, 617-632-6942, brian_wolpin@dfci.harvard.edu

    Brian Wolpin, MD, MPH

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030-4009

    Subrata Sen, PhD, 713-834-6040, ssen@mdanderson.org

    Eugene J. Koay, MD, PhD, ekoay@mdanderson.org

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-6805

    Kelsey Klute, MD, 402-559-1880, Kelsey.klute@unmc.edu

    Kelsey Klute, MD

    Recruiting

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61615

    Chandler Wilfong, MD, 309-691-4005, chandler.d.wilfong@osfhealthcare.org

    Chandler Wilfong, MD

    Recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15232

    Randall Brand, MD, 412-864-7516

    Randall Brand, MD

    Recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97201

    Rosalie Sears, PhD, 503-494-6885, searsr@ohsu.edu

    Rosalie Sears, PhD

    Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Shounak Majumder, MD

    Recruiting

  • University of California, San Francisco

    San Francisco, California, 94158

    Kimberly S. Kirkwood, MD, 415-502-0427, kim.kirkwood@ucsf.edu

    Kimberly S. Kirkwood, MD

    Recruiting

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

    Withdrawn

Other trials in United States

About this study

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
Non-Interventional Study
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-Interventional StudyOther

    Non-interventional study

Study groups in NCT06271291
Study groupRoleWhat they receive
ObservationalParticipants 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.
Receives: Other: Non-Interventional Study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (at enrollment)

  2. 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

    Measured: Up to study completion, as defined in description

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2024
  2. Study start12 Dec 2024
  3. Primary completion1 Nov 2029 (estimated)
  4. Study completion1 Nov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06271291
Sponsor's protocol ID
23-000161
Other IDs
U01CA210138, U24CA274496, NCI-2024-00504
Status last verified
Sep 2026
First submitted
14 Feb 2024
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatic Carcinoma, run by Mayo Clinic at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06271291.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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