Clinical trial NCT04970056: Pancreatic Cancer Early Detection Consortium
Official title: Pancreatic Cancer Early Detection Consortium
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreas Cancer
Pancreas Cyst
Pancreatic Ductal Adenocarcinoma
Genetic Predisposition
Lead sponsor: Arbor Research Collaborative for Health
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will accrue subjects who present for risk assessment at one of the participating sites based on history of:

* one or more family members with PDAC
* a pathogenic or likely pathogenic germline variant in a gene linked to PDAC risk
* personal history of PDAC with PGV in genes of research interest and/or part of a Familial Pancreatic Cancer kindred

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.

Eligibility criteria: 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 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

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.

Primary outcomes:
measure: Development of PDAC
timeFrame: Through study completion, an average of 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Scottsdale
country: United States
facility: Honor Health Research Institute
state: Arizona
city: Burbank
country: United States
facility: Providence Health and Services
state: California
city: Duarte
country: United States
facility: City of Hope
state: California
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Health
state: California
city: Newport Beach
country: United States
facility: Hoag
state: California
city: Orange
country: United States
facility: UC Irvine Health
state: California
city: Sacramento
country: United States
facility: UC Davis
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco (UCSF)
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Bloomington
country: United States
facility: Illinois CancerCare
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Worcester
country: United States
facility: Umass Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont/Corewell Health
state: Michigan
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack Meridian Health
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine At Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: White Plains
country: United States
facility: White Plains Hospital
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (Upmc)
state: Pennsylvania
city: Knoxville
country: United States
facility: University of Tennessee Graduate School of Medicine
state: Tennessee
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Center
state: Texas
city: Saint George
country: United States
facility: Intermountain Health
state: Utah
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
city: Richmond
country: United States
facility: VCU Massey Comprehensive Cancer Center
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Richmond
country: Australia
facility: Epworth HealthCare
state: Victoria
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Budapest
country: Hungary
facility: Semmelweis University, Institute of Pancreatic Diseases
city: Reykjavík
country: Iceland
facility: Landspitali University Hospital
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Lleida
country: Spain
facility: Hospital Universitari Arnau De Vilanova
city: Madrid
country: Spain
facility: Ramón y Cajal University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital (NCKUH)
state: Taiwan T.O.C.
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Liverpool
country: United Kingdom
facility: University of Liverpool
Study officials:
affiliation: UC San Diego Moores Cancer Center
name: Diane Simeone, MD
role: STUDY_CHAIR
References: