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Pancreatic Cancer Early Detection Consortium

NCT04970056 · Arbor Research Collaborative for Health
In plain English

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About this study
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.
Eligibility criteria
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 design
Enrollment target: 20000 participants
Age groups: adult, older_adult
Timeline
Starts: 2020-09-18
Estimated completion: 2030-12-31
Last updated: 2026-01-28
Primary outcomes
  • Development of PDAC (Through study completion, an average of 6 years)
Sponsor
Arbor Research Collaborative for Health · other
Contacts & investigators
ContactNaveen Fawas, BS · contact · naveen.fawaz@arborresearch.org · 7346654108
ContactJohn Graff, PhD · contact · john.graff@arborresearch.org · 7346654108
InvestigatorDiane Simeone, MD · study_chair, UC San Diego Moores Cancer Center
All locations (60)
Mayo Clinic ArizonaNot Yet Recruiting
Phoenix, Arizona, United States
Honor Health Research InstituteRecruiting
Scottsdale, Arizona, United States
Providence Health and ServicesRecruiting
Burbank, California, United States
City of HopeRecruiting
Duarte, California, United States
UC San Diego Moores Cancer CenterRecruiting
La Jolla, California, United States
Cedars-Sinai Medical CenterRecruiting
Los Angeles, California, United States
UCLA HealthRecruiting
Los Angeles, California, United States
HoagRecruiting
Newport Beach, California, United States
UC Irvine HealthRecruiting
Orange, California, United States
UC DavisRecruiting
Sacramento, California, United States
University of California, San Francisco (UCSF)Recruiting
San Francisco, California, United States
Yale UniversityRecruiting
New Haven, Connecticut, United States
Mayo Clinic JacksonvilleRecruiting
Jacksonville, Florida, United States
University of MiamiRecruiting
Miami, Florida, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Emory University HospitalRecruiting
Atlanta, Georgia, United States
Illinois CancerCareRecruiting
Bloomington, Illinois, United States
University of Chicago MedicineRecruiting
Chicago, Illinois, United States
NorthShore University HealthSystemRecruiting
Evanston, Illinois, United States
University of Kansas Medical CenterRecruiting
Kansas City, Kansas, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Umass Memorial Medical CenterRecruiting
Worcester, Massachusetts, United States
University of MichiganRecruiting
Ann Arbor, Michigan, United States
Beaumont/Corewell HealthRecruiting
Royal Oak, Michigan, United States
University of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
Hackensack Meridian HealthRecruiting
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer CenterNot Yet Recruiting
New York, New York, United States
Icahn School of Medicine At Mount SinaiRecruiting
New York, New York, United States
Columbia University Irving Medical CenterRecruiting
New York, New York, United States
University of Rochester Medical CenterRecruiting
Rochester, New York, United States
White Plains HospitalRecruiting
White Plains, New York, United States
The Ohio State UniversityRecruiting
Columbus, Ohio, United States
Oregon Health & Science UniversityRecruiting
Portland, Oregon, United States
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Fox Chase Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center (Upmc)Recruiting
Pittsburgh, Pennsylvania, United States
University of Tennessee Graduate School of MedicineRecruiting
Knoxville, Tennessee, United States
The University of Texas Southwestern Medical CenterTerminated
Dallas, Texas, United States
MD Anderson CenterWithdrawn
Houston, Texas, United States
Huntsman Cancer InstituteRecruiting
Salt Lake City, Utah, United States
Intermountain HealthRecruiting
St. George, Utah, United States
University of VirginiaRecruiting
Charlottesville, Virginia, United States
Inova Schar Cancer InstituteRecruiting
Fairfax, Virginia, United States
VCU Massey Comprehensive Cancer CenterRecruiting
Richmond, Virginia, United States
University of WashingtonRecruiting
Seattle, Washington, United States
Epworth HealthCareRecruiting
Richmond, Victoria, Australia
British Columbia Cancer AgencyRecruiting
Vancouver, British Columbia, Canada
University Health NetworkRecruiting
Toronto, Ontario, Canada
McGill University Health CentreRecruiting
Montreal, Quebec, Canada
Semmelweis University, Institute of Pancreatic DiseasesRecruiting
Budapest, Hungary
Landspitali University HospitalRecruiting
Reykjavik, Iceland
Sheba Medical CenterRecruiting
Ramat Gan, Israel
Azienda Ospedaliera Universitaria Integrata VeronaRecruiting
Verona, Italy
National Cancer Centre SingaporeRecruiting
Singapore, Singapore
Hospital Clínic de BarcelonaRecruiting
Barcelona, Spain
Hospital Universitari Arnau De VilanovaRecruiting
Lleida, Spain
Ramón y Cajal University HospitalRecruiting
Madrid, Spain
National Cheng Kung University Hospital (NCKUH)Recruiting
Tainan, Taiwan T.o.c., Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
University of LiverpoolRecruiting
Liverpool, United Kingdom
Pancreatic Cancer Early Detection Consortium · TrialPath