Pancreatic Cancer Screening of High-Risk Individuals in Arkansas

Study Overview
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Brief Summary
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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.

Official Title
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Pancreatic Cancer Screening of High-Risk Individuals in Arkansas

Conditions
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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

Intervention / Treatment
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* Other: Pancreatic Cancer Screening Pathway 1
* Other: Pancreatic Cancer Screening Pathway 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pathway 1<br>Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 1 | Other: Pancreatic Cancer Screening Pathway 1<br>* Screening with imaging and biomarker testing<br>|
| Active Comparator: Pathway2<br>Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 2 | Other: Pancreatic Cancer Screening Pathway 2<br>* Screening with biomarker testing only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of PC and precancerous lesion |  | 5 years |