Pancreatic Cancer Screening of High-Risk Individuals in Arkansas

Not Applicable

Withdrawn

• Conditions: Peutz-Jegher's Syndrome; Familial Atypical Mole-Malignant Melanoma Syndrome; Pancreatic Neoplasms; Ataxia Telangiectasia; BRCA2 Gene Mutation; Colorectal Neoplasms, Hereditary Nonpolyposis; Hereditary Pancreatitis; BRCA1 Gene Mutation
• Interventions: Other: Pancreatic Cancer Screening Pathway 1; Other: Pancreatic Cancer Screening Pathway 2

• Registration Number: NCT02309632
• Lead Sponsor: University of Arkansas

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-03
• Study First Submitted QC: 2014-12-03
• Study First Posted: 2014-12-05
• Study Start: 2015-11
• Status Verified: 2019-07
• Primary Completion: 2019-07-19
• Study Completion: 2019-07-19
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-07-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pathway 1	Pancreatic Cancer Screening Pathway 1	Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 1
Pathway2	Pancreatic Cancer Screening Pathway 2	Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 2

Primary Outcome Measures

Name	Time	Method
Detection rate of PC and precancerous lesion	5 years

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States