Pancreatic Cancer Screening of High-Risk Individuals in Arkansas
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Arkansas
- Locations
- 2
- Primary Endpoint
- Detection rate of PC and precancerous lesion
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Pathway 1
Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 1
Intervention: Pancreatic Cancer Screening Pathway 1 (Other)
Pathway2
Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 2
Intervention: Pancreatic Cancer Screening Pathway 2 (Other)
Outcomes
Primary Outcomes
Detection rate of PC and precancerous lesion
Time Frame: 5 years
Secondary Outcomes
No secondary outcomes reported