Pancreas CancerPRECEDENCT04970056
Pancreatic Cancer Early Detection Consortium
An observational study of Pancreas Cancer and Pancreas Cyst, run by Arbor Research Collaborative for Health at 60 sites in 11 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreas Cancer, Pancreas Cyst, Pancreatic Ductal Adenocarcinoma
- How many people
- 20,000 participants
- Where
- 60 sitesin 11 countries
- Study dates
- 18 Sep 2020to 31 Dec 2030
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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:
- 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 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
Show all 29Show fewer
- 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+
- 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
- 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:
- Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
- 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:
- Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
- 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
- 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)
Who cannot join
- Individuals not meeting the criteria above.
Trial locations and contacts
60 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
60 sites in 11 countries
United States45 sites, 42 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Sarah Volk, stomanic@med.umich.edu
Erika Koeppe, eskoeppe@med.umich.edu
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Halley Fowler, halley.fowler@emory.edu
Saurabh Chawla, MD, AGAF, FACG, FASGE
- Recruiting
Illinois CancerCare
Bloomington, Illinois, 61704
Carrie Geoffroy, cgeoffroy@illinoiscancercare.com
Kimberly Ku, MD
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Danielle Lynch, dlynch22@mgh.harvard.edu
Daniel Chung
- Recruiting
Providence Health and Services
Burbank, California, 91505
Taridu Ekanayake, emtaridu.ekanayake@providence.org
Ora Gordon, MD, MS. FACMG
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Evelyn Garcia, ev4pd@uvahealth.org
Todd Bauer, MD
- Recruiting
University of Chicago Medicine
Chicago, Illinois, 60637
Nia Howard, nia.howard@bsd.uchicago.edu
Sonia Kupfer, MD
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Ashley Tyson, 614-814-6487, Ashley.Tyson@osumc.edu
Philip Hart, MD
- Terminated
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
- Recruiting
City of Hope
Duarte, California, 91010
Diamond Ward, diward@coh.org
James Lin
- Recruiting
NorthShore University HealthSystem
Evanston, Illinois, 60201
Aram Rojas, arojas@northshore.org
Melissa Hogg, MD
- Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Salman Baig, Salman.Baig@inova.org
Raymond Wadlow, MD
- Recruiting
Hackensack Meridian Health
Hackensack, New Jersey, 07601
Christianna Torres, christianna.torres@hmhn.org
Rosario Ligresti, MD
- Withdrawn
MD Anderson Center
Houston, Texas, 77030
- Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Christian Glover, glover.christian@mayo.edu
Yan Bi
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Jodi Claybaugh, jclaybaugh@kumc.edu
Ajay Bansal, MD
- Recruiting
University of Tennessee Graduate School of Medicine
Knoxville, Tennessee, 37930
Tiffany Johnson, thjohnson@utmck.edu
James McLoughlin, MD
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Emma Vail, e2brooks@health.ucsd.edu
Diane Simeone, MD
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Jenny Frisendahl, jenny.frisendahl@cshs.org
Srinivas Gaddam
- Recruiting
UCLA Health
Los Angeles, California, 90095
Sophia Quiroz, SStokes@mednet.ucla.edu
Timothy Donahue, MD
- Recruiting
University of Miami
Miami, Florida, 33136
Casper Ruiz Ruiz, cxr1353@med.miami.edu
Dan Sussman
- Recruiting
Yale University
New Haven, Connecticut, 06510
Scott Merenda, scott.merenda@yale.edu
James Farrell
- Not yet recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10022
Jeffin Naduparambil, naduparj@mskcc.org
Vineet Rolston, MD
- Recruiting
Icahn School of Medicine At Mount Sinai
New York, New York, 10029
Joyce Serebrenik, joyce.serebrenik@mountsinai.org
Storey Harbison, storey.harbison@mssm.edu
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Katharine Godfrey, kb3217@cumc.columbia.edu
Fay Kastrinos
- Recruiting
Hoag
Newport Beach, California, 92663
Alexandria Adams, alexandria.adams@hoag.org
Zulma Loera, zulma.loera@hoag.org
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Suzanne Wessling, suzanne.wessling@unmc.edu
Kelsey Klute
- Recruiting
UC Irvine Health
Orange, California, 92868
Blake Johnson, blakej@hs.uci.edu
Jennifer Valerin, MD, PhD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Danny Clay, Daniel.Clay@Pennmedicine.upenn.edu
Bryson Katona
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Eberechukwu Muoneke, eberechukwu.muoneke@fccc.edu
David Weinberg, MD, MSc
- Not yet recruiting
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Michele Richardson, richardson.michele@mayo.edu
Michelle Anderson
- Recruiting
University of Pittsburgh Medical Center (Upmc)
Pittsburgh, Pennsylvania, 15232
Beth Dudley, dudleyre@upmc.edu
Randy Brand
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Dove Keith, keithd@ohsu.edu
Aaron Grossberg
- Recruiting
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Faith McFadden, mcfaddenfr@vcu.edu
Jose Trevino, MD
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Chelsea DiBella, chelsea_dibella@urmc.rochester.edu
Darren Carpizo
- Recruiting
Beaumont/Corewell Health
Royal Oak, Michigan, 48073
Tara Rangarajan, tara.rangarajan@corewellhealth.org
Dana Zakalik, MD
- Recruiting
UC Davis
Sacramento, California, 95817
Tanpreet Dodd, tkdodd@health.ucdavis.edu
Edward Kim, MD, PhD
- Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Jo Lyman, jo.anson@hci.utah.edu
Whitney Espinel, MMSc, GC
- Recruiting
University of California, San Francisco (UCSF)
San Francisco, California, 94143
Kurt Giles, PancreasCRC@ucsf.edu
Margaret Tempero, MD
- Recruiting
Honor Health Research Institute
Scottsdale, Arizona, 85258
Jeanette Dupree, jdupree@honorhealth.com
Erkut Borazanci, MD
- Recruiting
University of Washington
Seattle, Washington, 98195
Lisa Ann Lai, lail@uw.edu
Teri Brentnall
- Withdrawn
Intermountain Health
St. George, Utah, 84790
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Toni Basinski, 813.745.6360, Toni.Basinski@Moffitt.Org
Jenny Permuth
- Recruiting
White Plains Hospital
White Plains, New York, 10601
Griselda Cruz, grcruz@wphospital.org
Joshua Raff, MD
- Recruiting
Umass Memorial Medical Center
Worcester, Massachusetts, 01655
Paige Malone, paige.malone@umassmed.edu
James Lindberg, MD
Canada3 sites, 3 recruiting
- Recruiting
McGill University Health Centre
Montreal, Quebec
Adeline Cuggia, pancreas.surveillance@muhc.mcgill.ca
George Zogopoulos
- Recruiting
University Health Network
Toronto, Ontario
Spring Holter, spring.holter@uhn.ca
Robert Grant
- Recruiting
British Columbia Cancer Agency
Vancouver, British Columbia
Eugene Cheung, eugene.cheung1@bccancer.bc.ca
Intan Schrader
Spain3 sites, 3 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona
Eva Vaquero, evaquero@clinic.cat
Eva C Vaquero, MD, PhD
- Recruiting
Hospital Universitari Arnau De Vilanova
Lleida, 25198
Xavier Molero, xmolero@gss.cat
Xavier Molero, MD, PhD
- Recruiting
Ramón y Cajal University Hospital
Madrid
Julie Earl, julie.earl@live.co.uk
Julie Earl
Taiwan2 sites, 2 recruiting
- Recruiting
National Cheng Kung University Hospital (NCKUH)
Tainan, Taiwan T.o.c., 704
Yung-Yeh Su, yysu@nhri.edu.tw
Yan-Shen Shan
- Recruiting
National Taiwan University Hospital
Taipei
Wei-Chih David Liao, david.ntuh@gmail.com
Wei-Chih David Liao, MD, PhD
Australia1 site, 1 recruiting
- Recruiting
Epworth HealthCare
Richmond, Victoria, 3121
Ashleigh Poh, ashleigh.poh@epworth.org.au
Andrew Metz, MBBS, FRACP
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University, Institute of Pancreatic Diseases
Budapest
Zoltán Hajnády, hajnady.zoltan@semmelweis.hu
Péter Hegyi, MD, PhD, DSc
Iceland1 site, 1 recruiting
- Recruiting
Landspitali University Hospital
Reykjavik
Jóhanna Stefansdottir, johanste@landspitali.is
Sigurdís Haraldsdóttir, MD
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Maria Raitses, Maria.RaitsesGurevich@sheba.health.gov.il
Talia Golan
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Integrata Verona
Verona
Salvatore Paiella, salvatore.paiella@univr.it
Erica Secchettin, erica.secchettin@univr.it
Singapore1 site, 1 recruiting
- Recruiting
National Cancer Centre Singapore
Singapore, 168583
Caitlin Nicole, caitlin.nicole.s.v@nccs.com.sg
Meggie Huang Mochao, meggie.huang.m.c@nccs.com.sg
United Kingdom1 site, 1 recruiting
- Recruiting
University of Liverpool
Liverpool
Annabelle Boughey, europac@liverpool.ac.uk
Bill Greenhalf
About this study
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.
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic Cyst, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of PDAC
Diagnosis of PDAC
Measured: Through study completion, an average of 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start18 Sep 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arbor Research Collaborative for Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diane Simeone, MD, Study chair, UC San Diego Moores Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970056
- Sponsor's protocol ID
- PRECEDE
- Acronym
- PRECEDE
- Status last verified
- Jul 2026
- First submitted
- 21 Apr 2021
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Cancer Early Detection Consortium
- ClinicalTrials.gov ID
- NCT04970056
- Acronym / sponsor ID
- PRECEDE / PRECEDE
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Arbor Research Collaborative for HealthUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (29 listed)
- 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
- 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 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
Key exclusion criteria (1 listed)
- Individuals not meeting the criteria above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of PDAC
Time frame: Through study completion, an average of 6 years
Diagnosis of PDAC
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Derived from this study: PubMed 38626807Zogopoulos 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diane Simeone, MD study chair
UC San Diego Moores Cancer Center
60 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Cancer and Pancreas Cyst, run by Arbor Research Collaborative for Health at 60 sites in 11 countries.
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 29 inclusion and 1 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 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Canada, Spain, Taiwan, Australia and 6 more countries. 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 Naveen Fawas, BS (7346654108, naveen.fawaz@arborresearch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of PDAC (time frame: Through study completion, an average of 6 years). 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 NCT04970056, which also lists 1 linked publication.
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 22 Jul 2026.