Pancreatic Cancer Screening of High-Risk Individuals in Arkansas

Overview

100 subjects who have a family history of pancreatic cancer (PC), or known genetic syndromes associated with increased risk of pancreatic cancer, will be followed for five years. This data will be used to determine the pancreatic cancer and precancerous lesion detection rate in High Risk Individuals (HRIs). Subjects may agree to annual imaging and annual biomarkers or to biomarkers only.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 19, 2019

Interventions

  • Other: Pancreatic Cancer Screening Pathway 1
    • Screening with imaging and biomarker testing
  • Other: Pancreatic Cancer Screening Pathway 2
    • Screening with biomarker testing only

Arms, Groups and Cohorts

  • Active Comparator: Pathway 1
    • Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 1
  • Active Comparator: Pathway2
    • Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 2

Clinical Trial Outcome Measures

Primary Measures

  • Detection rate of PC and precancerous lesion
    • Time Frame: 5 years

Participating in This Clinical Trial

Inclusion Criteria

  • Have a family history of PC as listed below or who have one of the following syndromes: Peutz-Jeghers syndrome – STK11; BRCA 1 and 2; PALB2; ATM; FAMMM / P16; HNPCC (Lynch) / MMR genes; Hereditary pancreatitis – PRSS1 – Individuals with three or more affected blood relatives (1st, 2nd or 3rd degree) – Individuals with two or more affected blood relatives with PC, with at least one affected FDR, should be considered for screening. – Patients with a history of Peutz-Jeghers syndrome should be screened, regardless of family history of PC. – Patients with a known p16 (FAMMM syndrome) with one affected 1st or 2nd degree relative will be considered for screening. – Patients with a known BRCA1 or BRCA2 mutation with one affected 1st or 2nd degree relative should be considered for screening. – Patients with a known PALB2 mutation with one affected family member should be considered for screening. – Patients with a known Mismatch-repair gene-mutation carriers (Lynch syndrome) with one affected family member should be considered for screening. Exclusion Criteria:

  • Not candidates for surgery

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Arkansas
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kent D McKelvey, MD, Principal Investigator, University of Arkansas

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