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NCT04970056RecruitingAccepts Healthy Volunteers

Pancreatic Cancer Early Detection Consortium

Arbor Research Collaborative for Health

Start Date

9/18/2020

Completion Date

12/31/2030

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.

Eligibility Criteria

Age Range: 18 years to 90 years

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.

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Conditions

Pancreas CancerPancreas CystPancreatic Ductal AdenocarcinomaGenetic Predisposition

Locations

Mayo Clinic Arizona

Phoenix, Arizona 85054

United States

Honor Health Research Institute

Scottsdale, Arizona 85258

United States

Providence Health and Services

Burbank, California 91505

United States

City of Hope

Duarte, California 91010

United States

UC San Diego Moores Cancer Center

La Jolla, California 92093

United States

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

UCLA Health

Los Angeles, California 90095

United States

Hoag

Newport Beach, California 92663

United States

UC Irvine Health

Orange, California 92868

United States

UC Davis

Sacramento, California 95817

United States

University of California, San Francisco (UCSF)

San Francisco, California 94143

United States

Yale University

New Haven, Connecticut 06510

United States

Mayo Clinic Jacksonville

Jacksonville, Florida 32224

United States

University of Miami

Miami, Florida 33136

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Emory University Hospital

Atlanta, Georgia 30322

United States

Illinois CancerCare

Bloomington, Illinois 61704

United States

University of Chicago Medicine

Chicago, Illinois 60637

United States

NorthShore University HealthSystem

Evanston, Illinois 60201

United States

University of Kansas Medical Center

Kansas City, Kansas 66160

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Umass Memorial Medical Center

Worcester, Massachusetts 01655

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Beaumont/Corewell Health

Royal Oak, Michigan 48073

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

Hackensack Meridian Health

Hackensack, New Jersey 07601

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10022

United States

Icahn School of Medicine At Mount Sinai

New York, New York 10029

United States

Columbia University Irving Medical Center

New York, New York 10032

United States

University of Rochester Medical Center

Rochester, New York 14642

United States

White Plains Hospital

White Plains, New York 10601

United States

The Ohio State University

Columbus, Ohio 43210

United States

Oregon Health & Science University

Portland, Oregon 97239

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania 19111

United States

University of Pittsburgh Medical Center (Upmc)

Pittsburgh, Pennsylvania 15232

United States

University of Tennessee Graduate School of Medicine

Knoxville, Tennessee 37930

United States

The University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States

MD Anderson Center

Houston, Texas 77030

United States

Huntsman Cancer Institute

Salt Lake City, Utah 84112

United States

Intermountain Health

St. George, Utah 84790

United States

University of Virginia

Charlottesville, Virginia 22903

United States

Inova Schar Cancer Institute

Fairfax, Virginia 22031

United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia 23298

United States

University of Washington

Seattle, Washington 98195

United States

Epworth HealthCare

Richmond, Victoria 3121

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

Reykjavik,

Iceland

Sheba Medical Center

Ramat Gan,

Israel

Azienda Ospedaliera Universitaria Integrata Verona

Verona,

Italy

National Cancer Centre Singapore

Singapore, 168583

Singapore

Hospital Clínic de Barcelona

Barcelona,

Spain

Hospital Universitari Arnau De Vilanova

Lleida, 25198

Spain

Ramón y Cajal University Hospital

Madrid,

Spain

National Cheng Kung University Hospital (NCKUH)

Tainan, Taiwan T.o.c. 704

Taiwan

National Taiwan University Hospital

Taipei,

Taiwan

University of Liverpool

Liverpool,

United Kingdom