Pancreatic Cancer Early Detection Consortium
PRECEDE
1 other identifier
observational
20,000
11 countries
60
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2020
Longer than P75 for all trials
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 18, 2020
CompletedFirst Submitted
Initial submission to the registry
April 21, 2021
CompletedFirst Posted
Study publicly available on registry
July 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
April 22, 2026
June 1, 2025
10.3 years
April 21, 2021
April 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Development of PDAC
Diagnosis of PDAC
Through study completion, an average of 6 years
Study Arms (10)
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 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.
Eligibility Criteria
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
You may qualify if:
- 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:
- + 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.
- affected first degree relatives with PDAC; age 50+ or 10 years younger than earliest PDAC in family
- 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
- Familial Atypical Moles and Malignant Melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant; age 40+
- Peutz-Jegher syndrome with STK11 pathogenic or likely pathogenic variant; age 35+
- 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:
- ATM, BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant regardless of family history, age 50+
- + 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
- 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)
- +14 more criteria
You may not qualify if:
- Individuals not meeting the criteria above.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
Honor Health Research Institute
Scottsdale, Arizona, 85258, United States
Providence Health and Services
Burbank, California, 91505, United States
City of Hope
Duarte, California, 91010, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
UCLA Health
Los Angeles, California, 90095, United States
Hoag
Newport Beach, California, 92663, United States
UC Irvine Health
Orange, California, 92868, United States
UC Davis
Sacramento, California, 95817, United States
University of California, San Francisco (UCSF)
San Francisco, California, 94143, United States
Yale University
New Haven, Connecticut, 06510, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
University of Miami
Miami, Florida, 33136, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Illinois CancerCare
Bloomington, Illinois, 61704, United States
University of Chicago Medicine
Chicago, Illinois, 60637, United States
NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Umass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Beaumont/Corewell Health
Royal Oak, Michigan, 48073, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Hackensack Meridian Health
Hackensack, New Jersey, 07601, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10022, United States
Icahn School of Medicine At Mount Sinai
New York, New York, 10029, United States
Columbia University Irving Medical Center
New York, New York, 10032, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
White Plains Hospital
White Plains, New York, 10601, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Pittsburgh Medical Center (Upmc)
Pittsburgh, Pennsylvania, 15232, United States
University of Tennessee Graduate School of Medicine
Knoxville, Tennessee, 37930, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
MD Anderson Center
Houston, Texas, 77030, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Intermountain Health
St. George, Utah, 84790, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
University of Washington
Seattle, Washington, 98195, United States
Epworth HealthCare
Richmond, Victoria, 3121, Australia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
University Health Network
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Semmelweis University, Institute of Pancreatic Diseases
Budapest, Hungary
Landspitali University Hospital
Reykjavik, Iceland
Sheba Medical Center
Ramat Gan, Israel
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy
National Cancer Centre Singapore
Singapore, 168583, Singapore
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Universitari Arnau De Vilanova
Lleida, 25198, Spain
Ramón y Cajal University Hospital
Madrid, Spain
National Cheng Kung University Hospital (NCKUH)
Tainan, Taiwan T.o.c., 704, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
University of Liverpool
Liverpool, United Kingdom
Related Publications (1)
Zogopoulos G, Haimi I, Sanoba SA, Everett JN, Wang Y, Katona BW, Farrell JJ, Grossberg AJ, Paiella S, Klute KA, Bi Y, Wallace MB, Kwon RS, Stoffel EM, Wadlow RC, Sussman DA, Merchant NB, Permuth JB, Golan T, Raitses-Gurevich M, Lowy AM, Liau J, Jeter JM, Lindberg JM, Chung DC, Earl J, Brentnall TA, Schrader KA, Kaul V, Huang C, Chandarana H, Smerdon C, Graff JJ, Kastrinos F, Kupfer SS, Lucas AL, Sears RC, Brand RE, Parmigiani G, Simeone DM; PRECEDE Consortium. The Pancreatic Cancer Early Detection (PRECEDE) Study is a Global Effort to Drive Early Detection: Baseline Imaging Findings in High-Risk Individuals. J Natl Compr Canc Netw. 2024 Apr;22(3):158-166. doi: 10.6004/jnccn.2023.7097.
PMID: 38626807DERIVED
Biospecimen
A standardized procedure for collection and processing of human blood will be applied to all blood samples collected as part of the study. Barcoded samples will be stored at the clinical centers, and corresponding data will be entered into the study database. Any protocol deviations should also be recorded by each center. 60mL of blood is collected at baseline, 120mL annually, and 60mL at other events. Eligible individuals who are not seen in person for a clinic visit, who express interest in enrollment after initial contact, will be sent a copy of the IC document and a saliva collection kit by mail. Individuals in Cohort 5 may alternatively submit saliva or buccal swab samples without a clinic visit. Participants will return the signed consent and saliva sample.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Diane Simeone, MD
UC San Diego Moores Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2021
First Posted
July 21, 2021
Study Start
September 18, 2020
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2030
Last Updated
April 22, 2026
Record last verified: 2025-06