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Clinical Trials/NCT02309632
NCT02309632
Withdrawn
Not Applicable

Pancreatic Cancer Screening of High-Risk Individuals in Arkansas

University of Arkansas1 site in 1 countryNovember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Neoplasms, Hereditary Nonpolyposis
Sponsor
University of Arkansas
Locations
1
Primary Endpoint
Detection rate of PC and precancerous lesion
Status
Withdrawn
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 2015
End Date
July 19, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Detection rate of PC and precancerous lesion

Time Frame: 5 years

Study Sites (1)

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