Pancreatic Cancer Early Detection Consortium
Recruiting · NCT04970056 · Observational (researchers observe without assigning treatment) · Lead sponsor: Arbor Research Collaborative for Health
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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:
- 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 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)
Exclusion criteria
- Individuals not meeting the criteria above.
Where it is running
60 locations listed across 20 US states.
- 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
- Hoag - Newport Beach, 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
- Huntsman Cancer Institute - Salt Lake City, Utah, United States
- Intermountain Health - St. George, 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
- Hospital Clínic de Barcelona - Barcelona, Spain
- Semmelweis University, Institute of Pancreatic Diseases - Budapest, Hungary
- University of Liverpool - Liverpool, United Kingdom
- Hospital Universitari Arnau De Vilanova - Lleida, Spain
- Ramón y Cajal University Hospital - Madrid, Spain
- Sheba Medical Center - Ramat Gan, Israel
- Landspitali University Hospital - Reykjavik, Iceland
- National Cancer Centre Singapore - Singapore, Singapore
- National Taiwan University Hospital - Taipei, Taiwan
- Azienda Ospedaliera Universitaria Integrata Verona - Verona, Italy
- British Columbia Cancer Agency - Vancouver, British Columbia, Canada
- University Health Network - Toronto, Ontario, Canada
- McGill University Health Centre - Montreal, Quebec, Canada
- National Cheng Kung University Hospital (NCKUH) - Tainan, Taiwan T.o.c., Taiwan
- Epworth HealthCare - Richmond, Victoria, Australia