Back to resultsPancreatic Cancer Screening of High-Risk Individuals in Arkansas
Primary Purpose
Pancreatic Neoplasms, Peutz-Jegher's Syndrome, BRCA1 Gene Mutation
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pancreatic Cancer Screening Pathway 1
Pancreatic Cancer Screening Pathway 2
Sponsored by
About this trial
This is an interventional screening trial for Pancreatic Neoplasms
Eligibility Criteria
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
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pathway 1
Pathway2
Arm Description
Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 1
Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 2
Outcomes
Primary Outcome Measures
Detection rate of PC and precancerous lesion
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02309632
Brief Title
Pancreatic Cancer Screening of High-Risk Individuals in Arkansas
Official Title
Pancreatic Cancer Screening of High-Risk Individuals in Arkansas
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
November 2015 (Anticipated)
Primary Completion Date
July 19, 2019 (Actual)
Study Completion Date
July 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pathway 1
Arm Type
Active Comparator
Arm Description
Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 1
Arm Title
Pathway2
Arm Type
Active Comparator
Arm Description
Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 2
Intervention Type
Other
Intervention Name(s)
Pancreatic Cancer Screening Pathway 1
Intervention Description
Screening with imaging and biomarker testing
Intervention Type
Other
Intervention Name(s)
Pancreatic Cancer Screening Pathway 2
Intervention Description
Screening with biomarker testing only
Primary Outcome Measure Information:
Title
Detection rate of PC and precancerous lesion
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kent D McKelvey, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pancreatic Cancer Screening of High-Risk Individuals in Arkansas
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