ClinicalTrials.gg
RecruitingNCT04970056PRECEDEUpdated Oct 29, 2026

Pancreatic Cancer Early Detection Consortium

An observational study in Pancreas Cancer, Pancreas Cyst and Pancreatic Ductal Adenocarcinoma, sponsored by Arbor Research Collaborative for Health. Recruiting at 62 sites in 12 countries. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Arbor Research Collaborative for Health · Observational

From the registry’s dates

  • Started Sep 2020; still recruiting 6 years 1 month later.
Updated Oct 29, 2026First site in Germany3 sites added+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
20,000
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pancreas Cancer
  • Pancreas Cyst
  • Pancreatic Ductal Adenocarcinoma
  • Genetic Predisposition
03

In context

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.

This study's planned enrollment of 20,000 is above the median of 200 across 740 observational studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Arbor Research Collaborative for Health is the lead sponsor of 19 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Individuals not meeting the criteria above.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
20,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Development of PDAC

    Diagnosis of PDAC

    Time frame: Through study completion, an average of 6 years

07

Study locations

57 of 62 sites recruiting
08

References and documents

Publications

  • 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. PubMed 38626807 ↗

Individual participant data

Plan to share: Undecided

09

Updates

1 registry update since Sep 25, 2026
Sites
3 sites added, 1 site removed — first site in Germany
Show 3 added (2 United States, 1 Germany)
  • Corewell Health · Royal Oak, United States
  • Bon Secours Cancer Institute at St. Francis · Midlothian, United States
  • Essen University Hospital · Essen, Germany
Show 1 removed
  • Beaumont/Corewell Health · Royal Oak, United States
Oct 29, 2026
Site contacts
Changed at 5 sites. See the sites
Show 5 sites
  • UCLA Health · Los Angeles, United StatesContact person changed (no phone or email listed)Contact S•••@mednet.ucla.edu→S•••@mednet.ucla.edu
  • Hoag · Newport Beach, United StatesContact a•••@hoag.org→L•••@hoag.orgContact removed z•••@hoag.org
  • Huntsman Cancer Institute · Salt Lake City, United StatesContact j•••@hci.utah.edu→j•••@hci.utah.edu
  • University of Virginia · Charlottesville, United StatesContact e•••@uvahealth.org→e•••@uvahealth.org
  • Epworth HealthCare · Richmond, AustraliaContact a•••@epworth.org.au→H•••@epworth.org.au
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    3 sites added, 1 site removed — first site in Germany
    Show 3 added (2 United States, 1 Germany)
    • Corewell Health · Royal Oak, United States
    • Bon Secours Cancer Institute at St. Francis · Midlothian, United States
    • Essen University Hospital · Essen, Germany
    Show 1 removed
    • Beaumont/Corewell Health · Royal Oak, United States
    Site contacts Changed at 5 sites. See the sites
    Show 5 sites
    • UCLA Health · Los Angeles, United StatesContact person changed (no phone or email listed)Contact S•••@mednet.ucla.edu→S•••@mednet.ucla.edu
    • Hoag · Newport Beach, United StatesContact a•••@hoag.org→L•••@hoag.orgContact removed z•••@hoag.org
    • Huntsman Cancer Institute · Salt Lake City, United StatesContact j•••@hci.utah.edu→j•••@hci.utah.edu
    • University of Virginia · Charlottesville, United StatesContact e•••@uvahealth.org→e•••@uvahealth.org
    • Epworth HealthCare · Richmond, AustraliaContact a•••@epworth.org.au→H•••@epworth.org.au

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04970056
Lead sponsor
Arbor Research Collaborative for Health
Responsible party
Sponsor
First posted
Jul 21, 2021
Start date
Sep 18, 2020
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Oct 29, 2026

Study contacts

Naveen Fawas, BS
Contact
naveen.fawaz@arborresearch.org
7346654108
John Graff, PhD
Contact
john.graff@arborresearch.org
7346654108
Diane Simeone, MD
study chair · UC San Diego Moores Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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