Pancreatic Cancer Screening of High-Risk Individuals in Arkansas
Conditions
Pancreatic Neoplasms - Peutz-Jegher's Syndrome - BRCA1 Gene Mutation - BRCA2 Gene Mutation - Ataxia Telangiectasia - Familial Atypical Mole-Malignant Melanoma Syndrome - Colorectal Neoplasms, Hereditary Nonpolyposis - Hereditary Pancreatitis
Conditions: official terms
Ataxia Telangiectasia - Colorectal Neoplasms - Colorectal Neoplasms, Hereditary Nonpolyposis - Dysplastic Nevus Syndrome - Melanoma - Neoplasms - Pancreatic Neoplasms - Pancreatitis - Pancreatitis, Chronic - Peutz-Jeghers Syndrome - Syndrome - Telangiectasis
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Intervention
Name: Pancreatic Cancer Screening Pathway 1 Type: Other
Name: Pancreatic Cancer Screening Pathway 2 Type: Other
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Status: Not yet recruiting
Contact: Kent D McKelvey, MD - 501-526-4020 - McKelveyKentD@uams.edu
Start Date
May 2015
Completion Date
May 2025
Sponsors
University of Arkansas
Source
University of Arkansas
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page