The Pancreatic Cancer Early Detection (PRECEDE) Study is a Global Effort to Drive Early Detection: Baseline Imaging Findings in High-Risk Individuals

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George Zogopoulos McGill University Health Centre, Montreal, Quebec, Canada

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Ido Haimi New York University Langone Health, New York, NY

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Shenin A. Sanoba New York University Langone Health, New York, NY

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Jessica N. Everett New York University Langone Health, New York, NY

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Yifan Wang McGill University Health Centre, Montreal, Quebec, Canada

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Bryson W. Katona University of Pennsylvania Perelman School of Medicine, Philadelphia, PA

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James J. Farrell Yale School of Medicine, Yale University, New Haven, CT

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Aaron J. Grossberg Oregon Health & Science University, Portland, OR

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Salvatore Paiella General and Pancreatic Surgery Unit, Pancreas Institute, University of Verona, Verona, Italy

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Kelsey A. Klute University of Nebraska Medical Center, Omaha, NE

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Yan Bi Mayo Clinic, Jacksonville, FL

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Michael B. Wallace Mayo Clinic, Jacksonville, FL

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Richard S. Kwon Michigan Medicine, Ann Arbor, MI

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Elena M. Stoffel Michigan Medicine, Ann Arbor, MI

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Raymond C. Wadlow Inova Schar Cancer Institute, Fairfax, VA

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Daniel A. Sussman University of Miami Health System, Miami, FL

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Nipun B. Merchant University of Miami Health System, Miami, FL

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Jennifer B. Permuth Moffitt Cancer Center, Tampa, FL

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Talia Golan Sheba Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

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Maria Raitses-Gurevich Sheba Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

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Andrew M. Lowy UC San Diego Health, La Jolla, CA

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Joy Liau UC San Diego Health, La Jolla, CA

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Joanne M. Jeter Huntsman Cancer Institute, Salt Lake City, UT

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James M. Lindberg UMass Memorial Health, Worcester, MA

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Daniel C. Chung Massachusetts General Hospital and Harvard Medical School, Boston, MA

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Julie Earl Ramón y Cajal Health Research Institute, Madrid, Spain

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Teresa A. Brentnall University of Washington Medical Center, Seattle, WA

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Kasmintan A. Schrader BC Cancer, Vancouver, British Columbia, Canada

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Vivek Kaul University of Rochester Medical Center, Rochester, NY

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Chenchan Huang New York University Langone Health, New York, NY

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Hersh Chandarana New York University Langone Health, New York, NY

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Caroline Smerdon Arbor Research Collaborative for Health, Ann Arbor, MI

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John J. Graff Arbor Research Collaborative for Health, Ann Arbor, MI

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Fay Kastrinos Columbia University Irving Medical Center/Herbert Irving Comprehensive Cancer Center, New York, NY

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Sonia S. Kupfer University of Chicago, Chicago, IL

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Aimee L. Lucas Icahn School of Medicine at Mount Sinai, New York, NY

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Rosalie C. Sears Oregon Health & Science University, Portland, OR

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Randall E. Brand University of Pittsburgh, Pittsburgh, PA

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Giovanni Parmigiani Dana-Farber Cancer Institute and Harvard T.H. Chan School of Public Health, Boston, MA

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Diane M. Simeone New York University Langone Health, New York, NY

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on behalf of the PRECEDE Consortium
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on behalf of the PRECEDE Consortium
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Background: Pancreatic adenocarcinoma (PC) is a highly lethal malignancy with a survival rate of only 12%. Surveillance is recommended for high-risk individuals (HRIs), but it is not widely adopted. To address this unmet clinical need and drive early diagnosis research, we established the Pancreatic Cancer Early Detection (PRECEDE) Consortium. Methods: PRECEDE is a multi-institutional international collaboration that has undertaken an observational prospective cohort study. Individuals (aged 18–90 years) are enrolled into 1 of 7 cohorts based on family history and pathogenic germline variant (PGV) status. From April 1, 2020, to November 21, 2022, a total of 3,402 participants were enrolled in 1 of 7 study cohorts, with 1,759 (51.7%) meeting criteria for the highest-risk cohort (Cohort 1). Cohort 1 HRIs underwent germline testing and pancreas imaging by MRI/MR-cholangiopancreatography or endoscopic ultrasound. Results: A total of 1,400 participants in Cohort 1 (79.6%) had completed baseline imaging and were subclassified into 3 groups based on familial PC (FPC; n=670), a PGV and FPC (PGV+/FPC+; n=115), and a PGV with a pedigree that does not meet FPC criteria (PGV+/FPC–; n=615). One HRI was diagnosed with stage IIB PC on study entry, and 35.1% of HRIs harbored pancreatic cysts. Increasing age (odds ratio, 1.05; P<.001) and FPC group assignment (odds ratio, 1.57; P<.001; relative to PGV+/FPC–) were independent predictors of harboring a pancreatic cyst. Conclusions: PRECEDE provides infrastructure support to increase access to clinical surveillance for HRIs worldwide, while aiming to drive early PC detection advancements through longitudinal standardized clinical data, imaging, and biospecimen captures. Increased cyst prevalence in HRIs with FPC suggests that FPC may infer distinct biological processes. To enable the development of PC surveillance approaches better tailored to risk category, we recommend adoption of subclassification of HRIs into FPC, PGV+/FPC+, and PGV+/FPC– risk groups by surveillance protocols.

Submitted July 25, 2023; final revision received October 9, 2023; accepted for publication October 9, 2023.

A list of the PRECEDE Consortium collaborators is provided in Appendix 1 in the supplementary materials (available online with this article).

Author contributions: Study concept and design: Zogopoulos, Haimi, Simeone. Data acquisition: All authors. Data analysis and interpretation: Zogopoulos, Haimi, Sanoba, Everett, Wang, Parmigiani, Simeone. Funding acquisition: Zogopoulos, Kastrinos, Kupfer, Lucas, Sears, Brand, Parmigiani, Simeone. Administrative, technical, or material support: All authors. Supervision: Zogopoulos, Simeone. Writing—original draft: Zogopoulos, Haimi, Sanoba, Everett, Wang, Parmigiani, Simeone. Writing—review & editing: All authors.

Disclosures: Dr. Zogopoulos has disclosed receiving grant/research support from Immunovia. Dr. Farrell has disclosed serving as a member of the speaker’s bureau for Interpace Diagnostics. Dr. Paiella has disclosed serving as a consultant for Alpha Tau Medical. Dr. Golan has disclosed receiving grant/research support from AstraZeneca and Bristol Myers Squibb; serving as a consultant for AbbVie, AstraZeneca, Teva, and MSD Merck; and serving on a speaker’s bureau for AbbVie and Roche. Dr. Schrader has disclosed serving as a consultant for AstraZeneca Canada, Merck, and Precision Rx-Dx. Dr. Lucas has disclosed participating in research for Immunovia; serving as a scientific advisor for ClearNote Health and Immunovia; and serving as a consultant for Immunovia. Dr. Sears has disclosed serving as a scientific advisor for Rappta Therapeutics and Larkspur Biosciences; and receiving grant/research support from AstraZeneca and Cardiff Oncology. Dr. Brand has disclosed receiving grant/research support from Immunova and Freenome. Dr. Parmigiani has disclosed cofounding Phaeno Biotech; serving as a consultant for Delfi Diagnostics; and serving as a scientific advisor for REALM IDx. Dr. Simeone has disclosed serving as a scientific advisor for ClearNote Health, Interpace, Merck & Co., Bayer, and FibroGen; and receiving grant/research support from Micronoma, Immunovia, ClearNote Health, Biological Dynamics, and Tempus. The remaining authors have disclosed that they have not received any financial consideration from any person or organization to support the preparation, analysis, results, or discussion of this article.

Funding: Research reported in this publication was supported by an anonymous donor through NYU Langone (D.M. Simeone) and Ambry Genetics, TrovaNOW, Amazon Web Services, Project Purple, REALM IDx, and Invicro through the PRECEDE Consortium.

Disclaimer: The funders had no role in the design of the study; the collection, analysis, and interpretation of the data; the writing of the manuscript; or the decision to submit the manuscript for publication.

Supplementary material: Supplementary material associated with this article is available online at https://doi.org/10.6004/jnccn.2023.7097. The supplementary material has been supplied by the author(s) and appears in its originally submitted form. It has not been edited or vetted by JNCCN. All contents and opinions are solely those of the author. Any comments or questions related to the supplementary materials should be directed to the corresponding author.

Correspondence: George Zogopoulos, MD, PhD, Departments of Surgery and Oncology, McGill University, McGill University Health Centre, 1001 Decarie Boulevard, Room EM2.3210, Montreal, Quebec, H4A 3J1 Canada. Email: george.zogopoulos@mcgill.ca; and
Diane M. Simeone, MD, Department of Surgery and Department of Pathology, Perlmutter Cancer Center, New York University Langone Health, 240 East 38th Street, 20th Floor, New York, NY 10016. Email: diane.simeone@nyulangone.org

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