Pancreatic Cancer Early Detection Consortium (PRECEDE)

April 20, 2026 updated by: Arbor Research Collaborative for Health
The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct research on multiple aspects of early detection and prevention of pancreatic ductal adenocarcinoma (PDAC) by establishing a multisite cohort of individuals with family history of PDAC and/or individuals carrying pathogenic/likely pathogenic germline variants (PGVs) in genes linked to PDAC risk for longitudinal follow up.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The main objective of the PRECEDE Consortium is to build a shared resource to drive research in critical areas necessary for early detection and prevention of PDAC.

The PRECEDE Consortium is an observational prospective cohort study, with single or serial biosample collection (every 6-12 months) in defined high-risk groups.

A standardized procedure for collection and processing of human blood for the PRECEDE Consortium will be applied to all blood samples collected as part of the study. Barcoded samples will be stored at the clinical centers, using the specific labels for the PRECEDE study and corresponding data will be entered into the study database.

Clinical data and outcomes will be obtained from institutional databases or clinical records to correlate patient information with laboratory results from biospecimens obtained for research. Patients will be followed by their attending physician and receive the standard follow-up care after the procedure in which biospecimen was obtained. It is the intent that biospecimens will be made available to all consortium investigators.

Study Type

Observational

Enrollment (Estimated)

20000

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

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • Richmond, Victoria, Australia, 3121
        • Recruiting
        • Epworth Healthcare
        • Principal Investigator:
          • Andrew Metz, MBBS, FRACP
        • Contact:
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Recruiting
        • University Health Network
        • Principal Investigator:
          • Robert Grant
        • Contact:
    • Quebec
  • Hungary
      • Budapest, Hungary
        • Recruiting
        • Semmelweis University, Institute of Pancreatic Diseases
        • Principal Investigator:
          • Péter Hegyi, MD, PhD, DSc
        • Contact:
  • Iceland
      • Reykjavik, Iceland
        • Recruiting
        • Landspitali University Hospital
        • Principal Investigator:
          • Sigurdís Haraldsdóttir, MD
        • Contact:
  • Israel
      • Ramat Gan, Israel
        • Recruiting
        • Sheba Medical Center
        • Contact:
        • Principal Investigator:
          • Ido Laish
        • Principal Investigator:
          • Eitan Friedman
        • Principal Investigator:
          • Talia Golan
  • Italy
  • Singapore
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic de Barcelona
        • Contact:
        • Principal Investigator:
          • Eva C Vaquero, MD, PhD
        • Principal Investigator:
          • Leticia Moreira, MD, PhD
      • Lleida, Spain, 25198
        • Recruiting
        • Hospital Universitari Arnau de Vilanova
        • Contact:
        • Principal Investigator:
          • Xavier Molero, MD, PhD
      • Madrid, Spain
        • Recruiting
        • Ramon y Cajal University Hospital
        • Contact:
        • Principal Investigator:
          • Julie Earl
  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Principal Investigator:
          • Wei-Chih David Liao, MD, PhD
    • Taiwan T.o.c.
      • Tainan, Taiwan T.o.c., Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital (NCKUH)
        • Contact:
        • Principal Investigator:
          • Yan-Shen Shan
  • United Kingdom
      • Liverpool, United Kingdom
        • Recruiting
        • University of Liverpool
        • Contact:
        • Principal Investigator:
          • Bill Greenhalf
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Not yet recruiting
        • Mayo Clinic Arizona
        • Contact:
        • Principal Investigator:
          • Michelle Anderson
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • Honor Health Research Institute
        • Principal Investigator:
          • Erkut Borazanci, MD
        • Contact:
    • California
      • Burbank, California, United States, 91505
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Principal Investigator:
          • James Lin
        • Principal Investigator:
          • Greg Idos
        • Contact:
      • La Jolla, California, United States, 92093
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Principal Investigator:
          • Andy Lowy
        • Principal Investigator:
          • Joy Liau
        • Principal Investigator:
          • Diane Simeone
        • Contact:
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Srinivas Gaddam
        • Contact:
      • Los Angeles, California, United States, 90095
      • Newport Beach, California, United States, 92663
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health
        • Principal Investigator:
          • Jennifer Valerin, MD, PhD
        • Contact:
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis
        • Principal Investigator:
          • Edward Kim, MD, PhD
        • Contact:
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco (UCSF)
        • Contact:
        • Principal Investigator:
          • Margaret Tempero, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University
        • Contact:
        • Principal Investigator:
          • James Farrell
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Jacksonville
        • Principal Investigator:
          • Yan Bi
        • Contact:
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Principal Investigator:
          • Dan Sussman
        • Principal Investigator:
          • Nipun Merchant
        • Contact:
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Principal Investigator:
          • Jenny Permuth
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
        • Principal Investigator:
          • Saurabh Chawla, MD, AGAF, FACG, FASGE
        • Contact:
    • Illinois
      • Bloomington, Illinois, United States, 61704
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medicine
        • Contact:
        • Principal Investigator:
          • Sonia Kupfer, MD
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • NorthShore University Healthsystem
        • Contact:
        • Principal Investigator:
          • Melissa Hogg, MD
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Principal Investigator:
          • Ajay Bansal, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Daniel Chung
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • UMass Memorial Medical Center
        • Contact:
        • Principal Investigator:
          • James Lindberg, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
      • Royal Oak, Michigan, United States, 48073
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Kelsey Klute
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack Meridian Health
        • Principal Investigator:
          • Rosario Ligresti, MD
        • Contact:
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Principal Investigator:
          • Fay Kastrinos
        • Contact:
      • New York, New York, United States, 10029
      • New York, New York, United States, 10022
        • Not yet recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
        • Principal Investigator:
          • Vineet Rolston, MD
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Medical Center
        • Principal Investigator:
          • Darren Carpizo
        • Principal Investigator:
          • Vivek Kaul
        • Contact:
      • White Plains, New York, United States, 10601
        • Recruiting
        • White Plains Hospital
        • Contact:
        • Principal Investigator:
          • Joshua Raff, MD
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Contact:
        • Principal Investigator:
          • Philip Hart, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
        • Principal Investigator:
          • Aaron Grossberg
        • Principal Investigator:
          • Brett Sheppard
        • Principal Investigator:
          • Rosie Sears
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • Fox Chase Cancer Center
        • Principal Investigator:
          • David Weinberg, MD, MSc
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Medical Center (UPMC)
        • Contact:
        • Principal Investigator:
          • Randy Brand
    • Tennessee
      • Knoxville, Tennessee, United States, 37930
        • Recruiting
        • University of Tennessee Graduate School of Medicine
        • Principal Investigator:
          • James McLoughlin, MD
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75390
        • Terminated
        • The University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Withdrawn
        • MD Anderson Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute
        • Contact:
        • Principal Investigator:
          • Whitney Espinel, MMSc, GC
      • St. George, Utah, United States, 84790
        • Recruiting
        • Intermountain Health
        • Principal Investigator:
          • Maricel Purcell, APRN
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia
        • Principal Investigator:
          • Todd Bauer, MD
        • Contact:
        • Principal Investigator:
          • Kathleen Haden, ANP
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Schar Cancer Institute
        • Contact:
        • Principal Investigator:
          • Raymond Wadlow, MD
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • VCU Massey Comprehensive Cancer Center
        • Principal Investigator:
          • Jose Trevino, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington
        • Principal Investigator:
          • Teri Brentnall
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study will accrue subjects who present for risk assessment at one of the participating sites based on history of:

  • one or more family members with PDAC
  • a pathogenic or likely pathogenic germline variant in a gene linked to PDAC risk
  • personal history of PDAC with PGV in genes of research interest and/or part of a Familial Pancreatic Cancer kindred

Description

Inclusion Criteria:

Individuals from the following groups who present for clinical evaluation and assessment of PDAC risk at any of the participating sites can be offered participation in the PRECEDE database:

Cohort 1

Individuals without history of PDAC meeting any of the following criteria:

  1. 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; age 50+ or ≤10 years younger than earliest PDAC in family at time of diagnosis.
  2. 2 affected first degree relatives with PDAC; age 50+ or 10 years younger than earliest PDAC in family
  3. BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, MSH6, PMS2, EPCAM pathogenic or likely pathogenic variant AND 1 first or second degree relative with PDAC; age 50+ or 10 years younger than earliest PDAC in family
  4. Familial Atypical Moles and Malignant Melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant; age 40+
  5. Peutz-Jegher syndrome with STK11 pathogenic or likely pathogenic variant; age 35+
  6. Hereditary pancreatitis with PRSS1 pathogenic or likely pathogenic variant and history of pancreatitis; age 40+

Cohort 2

Individuals without history of PDAC meeting any of the following criteria:

  1. ATM, BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant regardless of family history, age 50+
  2. 2+ relatives with PDAC on the same side of family, any degree of relation, not meeting other criteria above; age 50+ or 10 years younger than earliest PDAC in family
  3. 1 first degree relative with PDAC ≤ age 45; age up to 10 years younger than PDAC diagnosis in family member

Cohort 3 Individual meeting criteria for Cohorts 1 or 2 EXCEPT age (i.e. too young to qualify for Cohorts 1 or 2)

Cohort 4 Individuals without history of PDAC presenting for evaluation who do not meet any criteria for 1-3, 6, or the Cyst Cohort.

Cohort 5 Individuals without history of PDAC who are not otherwise engaged in pancreas surveillance at a participating site may be invited to participate in the PRECEDE database and to donate a biosample (e.g. blood, saliva, and/or buccal swab) for discovery studies. This may include relatives of individuals in Cohorts 1-4,6, and the Cyst Cohort.

Cohort 6a

Individuals diagnosed with PDAC or pancreatic high-grade dysplasia after enrollment in PRECEDE meeting any of the following criteria:

  1. Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
  2. Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11

Cohort 6b

Individuals with a personal history of PDAC or pancreatic high-grade dysplasia meeting any of the following criteria:

  1. Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
  2. Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11
  3. Diagnosed ≤ age 45

Cohort 6c Individuals with newly diagnosed early stage (stage I or stage II) PDAC seen at a PRECEDE site that do not meet the criteria for 6a or 6b.

Cohort 6d Individuals with PDAC seen at a PRECEDE site that do not meet the criteria for 6a, 6b, or 6c.

Cyst Cohort Individuals with a personal history of a pancreatic cystic neoplasm not meeting any criteria for Cohorts 1-3 or 6 (no known family history of PDAC, no known pathogenic germline variants linked to PDAC risk)

Exclusion Criteria:

  • Individuals not meeting the criteria above.

Study Plan

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

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Cohort 1

Individuals without history of PDAC meeting any of the following criteria:

  1. 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; age 50+ or ≤10 years younger than earliest PDAC in family at time of diagnosis.
  2. 2 affected first degree relatives with PDAC; age 50+ or 10 years younger than earliest PDAC in family
  3. BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, MSH6, PMS2, EPCAM pathogenic or likely pathogenic variant AND 1 first or second degree relative with PDAC; age 50+ or 10 years younger than earliest PDAC in family
  4. Familial Atypical Moles and Malignant Melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant; age 40+
  5. Peutz-Jegher syndrome with STK11 pathogenic or likely pathogenic variant; age 35+
  6. Hereditary pancreatitis with PRSS1 pathogenic or likely pathogenic variant and history of pancreatitis; age 40+
Cohort 2

Individuals without history of PDAC meeting any of the following criteria:

  1. ATM, BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant regardless of family history, age 50+
  2. 2+ relatives with PDAC on the same side of family, any degree of relation, not meeting other criteria above; age 50+ or 10 years younger than earliest PDAC in family
  3. 1 FDR with PDAC ≤ age 45; age up to 10 years younger than PDAC diagnosis in family member
Cohort 3
Individual meeting criteria for Cohorts 1 or 2 EXCEPT age (i.e. too young to qualify for Cohorts 1 or 2)
Cohort 4
Individuals without history of PDAC presenting for evaluation who do not meet any criteria for 1-3, 6, or the Cyst Cohort.
Cohort 5
Individuals without history of PDAC who are not otherwise engaged in pancreas surveillance at a participating site may be invited to participate in the PRECEDE database and to donate a biosample (e.g. blood, saliva, and/or buccal swab) for discovery studies. This may include relatives of individuals in Cohorts 1-4,6, and the Cyst Cohort.
Cyst Cohort
Individuals with a personal history of a pancreatic cystic neoplasm not meeting any criteria for Cohorts 1-3 or 6 (no known family history of PDAC, no known pathogenic germline variants linked to PDAC risk)
Cohort 6c
Individuals with newly diagnosed early stage (stage I or stage II) PDAC seen at a PRECEDE site that do not meet the criteria for 6a or 6b.
Cohort 6a

Individuals diagnosed with PDAC or pancreatic high-grade dysplasia after enrollment in PRECEDE meeting any of the following criteria:

  1. Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
  2. Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11
Cohort 6b

Individuals with a personal history of PDAC or pancreatic high-grade dysplasia meeting any of the following criteria:

  1. Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
  2. Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11
  3. Diagnosed ≤ age 45
Cohort 6d
Individuals with PDAC seen at a PRECEDE site that do not meet the criteria for 6a, 6b, or 6c.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of PDAC
Time Frame: Through study completion, an average of 6 years
Diagnosis of PDAC
Through study completion, an average of 6 years

Collaborators and Investigators

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

Sponsor

Arbor Research Collaborative for Health

Investigators

  • Study Chair: Diane Simeone, MD, UC San Diego Moores Cancer Center

Publications and helpful links

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

General Publications

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 Major Dates

Study Start (Actual)

September 18, 2020

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

April 21, 2021

First Submitted That Met QC Criteria

July 19, 2021

First Posted (Actual)

July 21, 2021

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRECEDE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Ductal Adenocarcinoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe