Pancreatic Cancer Early Detection Consortium
- Conditions
- Pancreatic Ductal AdenocarcinomaPancreas CancerPancreas CystGenetic Predisposition
- Registration Number
- NCT04970056
- Lead Sponsor
- Arbor Research Collaborative for Health
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10000
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
- 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 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 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
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)
- Individuals not meeting the criteria above.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Development of PDAC Through study completion, an average of 6 years Diagnosis of PDAC
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (59)
Hospital Universitari Arnau De Vilanova
🇪🇸Lleida, Spain
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
Honor Health Research Institute
🇺🇸Scottsdale, Arizona, United States
Providence Health and Services
🇺🇸Burbank, California, United States
City of Hope
🇺🇸Duarte, California, United States
UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
UCLA Health
🇺🇸Los Angeles, California, United States
UC Irvine Health
🇺🇸Orange, California, United States
UC Davis
🇺🇸Sacramento, California, United States
University of California, San Francisco (UCSF)
🇺🇸San Francisco, California, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Illinois CancerCare
🇺🇸Bloomington, Illinois, United States
University of Chicago Medicine
🇺🇸Chicago, Illinois, United States
NorthShore University HealthSystem
🇺🇸Evanston, Illinois, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Umass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Beaumont/Corewell Health
🇺🇸Royal Oak, Michigan, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Hackensack Meridian Health
🇺🇸Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Icahn School of Medicine At Mount Sinai
🇺🇸New York, New York, United States
Columbia University Irving Medical Center
🇺🇸New York, New York, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
White Plains Hospital
🇺🇸White Plains, New York, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center (Upmc)
🇺🇸Pittsburgh, Pennsylvania, United States
University of Tennessee Graduate School of Medicine
🇺🇸Knoxville, Tennessee, United States
The University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
MD Anderson Center
🇺🇸Houston, Texas, United States
Intermountain Health
🇺🇸Saint George, Utah, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Inova Schar Cancer Institute
🇺🇸Fairfax, Virginia, United States
VCU Massey Comprehensive Cancer Center
🇺🇸Richmond, Virginia, United States
University of Washington
🇺🇸Seattle, Washington, United States
Epworth HealthCare
🇦🇺Richmond, Victoria, 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
🇮🇸Reykjavík, Iceland
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Azienda Ospedaliera Universitaria Integrata Verona
🇮🇹Verona, Italy
National Cancer Centre Singapore
🇸🇬Singapore, Singapore
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Ramón y Cajal University Hospital
🇪🇸Madrid, Spain
National Cheng Kung University Hospital (NCKUH)
🇨🇳Tainan, Taiwan T.O.C., Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
University of Liverpool
🇬🇧Liverpool, United Kingdom