Pancreatic Cancer Early Detection Consortium

Pancreas Cancer Clinical Trial

— PRECEDE  

Official title:

Pancreatic Cancer Early Detection Consortium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04970056
• Other study ID #: PRECEDE
• Status: Recruiting
• Start date: September 18, 2020
• Est. completion date: December 31, 2030

Study information

• Verified date: June 2024
• Source: Arbor Research Collaborative for Health
• Contact: Naveen Fawas, BS
• Phone: 7346654108
• Email: naveen.fawaz[@]arborresearch.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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 6

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

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.

Related Conditions & MeSH terms

• Genetic Predisposition
• Genetic Predisposition to Disease
• Pancreas Cancer
• Pancreas Cyst
• Pancreatic Cyst
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Neoplasms

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Uhn Mount Sinai Hospital	Toronto	Ontario
Canada	British Columbia Cancer Agency	Vancouver	British Columbia
Hungary	Semmelweis University Department of Pancreatic Disorders	Budapest
Iceland	Landspitali University Hospital	Reykjavík
Israel	Sheba Medical Center	Ramat Gan
Italy	Azienda Ospedaliera Universitaria Integrata Verona	Verona
Singapore	National Cancer Center of Singapore	Singapore
Spain	Ramón y Cajal University Hospital	Madrid
Taiwan	National Cheng Kung University Hospital (NCKUH)	Tainan	Taiwan T.o.c.
United Kingdom	University of Liverpool	Liverpool
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	Illinois CancerCare	Bloomington	Illinois
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Providence Health and Services	Burbank	California
United States	University of Chicago Medicine	Chicago	Illinois
United States	The Ohio State University	Columbus	Ohio
United States	The University of Texas Southwestern Medical Center	Dallas	Texas
United States	City of Hope	Duarte	California
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	Inova Schar Cancer Institute	Fairfax	Virginia
United States	Hackensack Meridian Health	Hackensack	New Jersey
United States	MD Anderson Center	Houston	Texas
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	Kansas University Medical Center	Kansas City	Kansas
United States	University of Tennessee Graduate School of Medicine	Knoxville	Tennessee
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	University of Miami	Miami	Florida
United States	Yale University	New Haven	Connecticut
United States	Columbia University Irving Medical Center	New York	New York
United States	Icahn School of Medicine At Mount Sinai	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	UC Irvine Health	Orange	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	University of Pittsburgh Medical Center (Upmc)	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	VCU Massey Cancer Center	Richmond	Virginia
United States	University of Rochester Medical Center	Rochester	New York
United States	Beaumont/Corewell Health	Royal Oak	Michigan
United States	UC Davis	Sacramento	California
United States	Intermountain Health	Saint George	Utah
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	University of California, San Francisco (UCSF)	San Francisco	California
United States	Honor Health Research Institute	Scottsdale	Arizona
United States	University of Washington	Seattle	Washington
United States	Moffitt Cancer Center	Tampa	Florida
United States	Umass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Arbor Research Collaborative for Health

Countries where clinical trial is conducted

United States,  Canada,  Hungary,  Iceland,  Israel,  Italy,  Singapore,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of PDAC	Diagnosis of PDAC	Through study completion, an average of 6 years