PRECEDE: Pancreatic Cancer Early Detection Consortium

Sponsor
Arbor Research Collaborative for Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT04970056
Collaborator
(none)
8,000
30
123.4
266.7
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    8000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Pancreatic Cancer Early Detection Consortium
    Actual Study Start Date :
    Sep 18, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2030
    Anticipated Study Completion Date :
    Dec 31, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    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 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.

    Cohort 6

    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)

    Outcome Measures

    Primary Outcome Measures

    1. Development of PDAC [Through study completion, an average of 6 years]

      Diagnosis of PDAC

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Duarte California United States 91010
    2 UC San Diego Moores Cancer Center La Jolla California United States 92093
    3 Cedars-Sinai Medical Center Los Angeles California United States 90048
    4 Yale University New Haven Connecticut United States 06510
    5 Mayo Clinic Jacksonville Jacksonville Florida United States 32224
    6 University of Miami Miami Florida United States 33136
    7 Moffitt Cancer Center Tampa Florida United States 33612
    8 University of Chicago Medicine Chicago Illinois United States 60637
    9 Massachusetts General Hospital Boston Massachusetts United States 02114
    10 Umass Memorial Medical Center Worcester Massachusetts United States 01655
    11 University of Michigan Ann Arbor Michigan United States 48109
    12 University of Nebraska Medical Center Omaha Nebraska United States 68198
    13 New York University Langone Health New York New York United States 10016
    14 Icahn School of Medicine At Mount Sinai New York New York United States 10029
    15 Columbia University Irving Medical Center New York New York United States 10032
    16 University of Rochester Medical Center Rochester New York United States 14642
    17 Oregon Health & Science University Portland Oregon United States 97239
    18 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    19 University of Pittsburgh Medical Center (Upmc) Pittsburgh Pennsylvania United States 15232
    20 MD Anderson Center Houston Texas United States 77030
    21 Huntsman Cancer Institute Salt Lake City Utah United States 84112
    22 Inova Schar Cancer Institute Fairfax Virginia United States 22031
    23 University of Washington Seattle Washington United States 98195
    24 British Columbia Cancer Agency Vancouver British Columbia Canada
    25 Uhn Mount Sinai Hospital Toronto Ontario Canada
    26 McGill University Health Centre Montreal Quebec Canada
    27 Sheba Medical Center Ramat Gan Israel
    28 Azienda Ospedaliera Universitaria Integrata Verona Verona Italy
    29 Ramón y Cajal University Hospital Madrid Spain
    30 University of Liverpool Liverpool United Kingdom

    Sponsors and Collaborators

    • Arbor Research Collaborative for Health

    Investigators

    • Study Chair: Diane Simeone, MD, New York University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arbor Research Collaborative for Health
    ClinicalTrials.gov Identifier:
    NCT04970056
    Other Study ID Numbers:
    • PRECEDE
    First Posted:
    Jul 21, 2021
    Last Update Posted:
    Jul 18, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 18, 2022