Pancreatic Cancer Early Detection Consortium

Status: Recruiting
Location: See all (55) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
View:

⁃ 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)

Locations
United States
Arizona
Mayo Clinic Arizona
NOT_YET_RECRUITING
Phoenix
Honor Health Research Institute
RECRUITING
Scottsdale
California
Providence Health and Services
RECRUITING
Burbank
City of Hope
RECRUITING
Duarte
UC San Diego Moores Cancer Center
RECRUITING
La Jolla
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
UCLA Health
RECRUITING
Los Angeles
UC Irvine Health
NOT_YET_RECRUITING
Orange
UC Davis
RECRUITING
Sacramento
University of California, San Francisco (UCSF)
RECRUITING
San Francisco
Connecticut
Yale University
RECRUITING
New Haven
Florida
Mayo Clinic Jacksonville
RECRUITING
Jacksonville
University of Miami
RECRUITING
Miami
Moffitt Cancer Center
RECRUITING
Tampa
Georgia
Emory University Hospital
NOT_YET_RECRUITING
Atlanta
Illinois
Illinois CancerCare
RECRUITING
Bloomington
University of Chicago Medicine
RECRUITING
Chicago
NorthShore University HealthSystem
RECRUITING
Evanston
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Umass Memorial Medical Center
RECRUITING
Worcester
Michigan
University of Michigan
RECRUITING
Ann Arbor
Beaumont/Corewell Health
RECRUITING
Royal Oak
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
New Jersey
Hackensack Meridian Health
RECRUITING
Hackensack
New York
Columbia University Irving Medical Center
RECRUITING
New York
Icahn School of Medicine At Mount Sinai
RECRUITING
New York
University of Rochester Medical Center
RECRUITING
Rochester
White Plains Hospital
RECRUITING
White Plains
Ohio
The Ohio State University
RECRUITING
Columbus
Oregon
Oregon Health & Science University
RECRUITING
Portland
Pennsylvania
Fox Chase Cancer Center
RECRUITING
Philadelphia
University of Pennsylvania
RECRUITING
Philadelphia
University of Pittsburgh Medical Center (Upmc)
RECRUITING
Pittsburgh
Tennessee
University of Tennessee Graduate School of Medicine
RECRUITING
Knoxville
Texas
The University of Texas Southwestern Medical Center
RECRUITING
Dallas
MD Anderson Center
WITHDRAWN
Houston
Utah
Intermountain Health
RECRUITING
Saint George
Huntsman Cancer Institute
RECRUITING
Salt Lake City
Virginia
Inova Schar Cancer Institute
RECRUITING
Fairfax
VCU Massey Comprehensive Cancer Center
RECRUITING
Richmond
Washington
University of Washington
RECRUITING
Seattle
Other Locations
Australia
Epworth HealthCare
RECRUITING
Richmond
Canada
McGill University Health Centre
RECRUITING
Montreal
University Health Network
RECRUITING
Toronto
British Columbia Cancer Agency
RECRUITING
Vancouver
Hungary
Semmelweis University, Institute of Pancreatic Diseases
RECRUITING
Budapest
Iceland
Landspitali University Hospital
RECRUITING
Reykjavík
Israel
Sheba Medical Center
RECRUITING
Ramat Gan
Italy
Azienda Ospedaliera Universitaria Integrata Verona
RECRUITING
Verona
Singapore
National Cancer Centre Singapore
RECRUITING
Singapore
Spain
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Ramón y Cajal University Hospital
RECRUITING
Madrid
Taiwan
National Cheng Kung University Hospital (NCKUH)
RECRUITING
Tainan
United Kingdom
University of Liverpool
RECRUITING
Liverpool
Contact Information
Primary
Naveen Fawas, BS
naveen.fawaz@arborresearch.org
7346654108
Backup
John Graff, PhD
john.graff@arborresearch.org
7346654108
Time Frame
Start Date: 2020-09-18
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 10000
Treatments
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 FDR 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.
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)
Cohort 6a
Individuals diagnosed with PDAC 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 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
Related Therapeutic Areas
Sponsors
Leads: Arbor Research Collaborative for Health

This content was sourced from clinicaltrials.gov