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Pancreatic Cancer Early Detection Consortium

Pancreatic Cancer Early Detection Consortium

Recruiting
18-90 years
All
Phase N/A

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Overview

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.

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.

Study details
    Pancreas Cancer
    Pancreas Cyst
    Pancreatic Ductal Adenocarcinoma
    Genetic Predisposition

NCT04970056

Arbor Research Collaborative for Health

26 June 2024

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