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Official Title

Pancreatic Cancer Early Detection Consortium

Sponsor
Arbor Research Collaborative for Health
Enrollment
10,000
Timeline
Sep 2020 → Dec 2030
About This Study

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 Criteria

Inclusion Criteria

  • 1Individuals 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:
  • 2Cohort 1
  • 3Individuals without history of PDAC meeting any of the following criteria:
  • 42+ 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.
  • 52 affected first degree relatives with PDAC; age 50+ or 10 years younger than earliest PDAC in family
  • 6BRCA1, 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
  • 7Familial Atypical Moles and Malignant Melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant; age 40+
  • 8Peutz-Jegher syndrome with STK11 pathogenic or likely pathogenic variant; age 35+
  • 9Hereditary pancreatitis with PRSS1 pathogenic or likely pathogenic variant and history of pancreatitis; age 40+
  • 10Cohort 2
  • 11Individuals without history of PDAC meeting any of the following criteria:
  • 12ATM, BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant regardless of family history, age 50+
  • 132+ 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
  • 141 first degree relative with PDAC ≤ age 45; age up to 10 years younger than PDAC diagnosis in family member
  • 15Cohort 3 Individual meeting criteria for Cohorts 1 or 2 EXCEPT age (i.e. too young to qualify for Cohorts 1 or 2)
  • 16Cohort 4 Individuals without history of PDAC presenting for evaluation who do not meet any criteria for 1-3, 6, or the Cyst Cohort.
  • 17Cohort 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.
  • 18Cohort 6a
  • 19Individuals diagnosed with PDAC after enrollment in PRECEDE meeting any of the following criteria:
  • 20Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
  • 21Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11
  • 22Cohort 6b
  • 23Individuals with a personal history of PDAC meeting any of the following criteria:
  • 24Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
  • 25Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11
  • 26Diagnosed ≤ age 45
  • 27Cyst 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

  • 1Individuals not meeting the criteria above.

Locations

60 sites participating in this study

Emory University Hospital

Atlanta, Georgia 30322

Recruiting

Saurabh Chawla, MD, AGAF, FACG, FASGE

Mayo Clinic Arizona

Phoenix, Arizona 85054

Recruiting

Michelle Anderson

Honor Health Research Institute

Scottsdale, Arizona 85258

Recruiting

Erkut Borazanci, MD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →