Pancreatic Cancer Screening of High-Risk Individuals in Arkansas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2019-07-19

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.

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Detailed Description

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Pathway 1

Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 1

Group Type ACTIVE_COMPARATOR

Pancreatic Cancer Screening Pathway 1

Intervention Type OTHER

Screening with imaging and biomarker testing

Pathway2

Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 2

Group Type ACTIVE_COMPARATOR

Pancreatic Cancer Screening Pathway 2

Intervention Type OTHER

Screening with biomarker testing only

Interventions

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Pancreatic Cancer Screening Pathway 1

Screening with imaging and biomarker testing

Intervention Type OTHER

Pancreatic Cancer Screening Pathway 2

Screening with biomarker testing only

Intervention Type OTHER

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.