Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Genders
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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Screening
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Pathway 1
Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 1
  • Other: Pancreatic Cancer Screening Pathway 1
    Screening with imaging and biomarker testing
Active Comparator
Pathway2
Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 2
  • Other: Pancreatic Cancer Screening Pathway 2
    Screening with biomarker testing only

Recruiting Locations

More Details

NCT ID
NCT02309632
Status
Active, not recruiting
Sponsor
University of Arkansas

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.