Ataxia Telangiectasia, BRCA1 Gene Mutation, BRCA2 Gene Mutation, Colorectal Neoplasms, Hereditary Nonpolyposis, Familial Atypical Mole-Malignant Melanoma Syndrome, Hereditary Pancreatitis, Pancreatic Neoplasms, Peutz-Jegher's Syndrome
Conditions
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.
Interventions
OTHERPancreatic Cancer Screening Pathway 1
Screening with imaging and biomarker testing
OTHERPancreatic Cancer Screening Pathway 2
Screening with biomarker testing only
Sponsors
University of Arkansas
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection rate of PC and precancerous lesion | 5 years |
Countries
United States
Outcome results
None listed