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Pancreatic Cancer Screening of High-Risk Individuals in Arkansas

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT02309632
First received: December 3, 2014
Last updated: June 12, 2017
Last verified: June 2017
  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.

Condition Intervention
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 Other: Pancreatic Cancer Screening Pathway 1 Other: Pancreatic Cancer Screening Pathway 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Screening
Official Title: Pancreatic Cancer Screening of High-Risk Individuals in Arkansas

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Detection rate of PC and precancerous lesion [ Time Frame: 5 years ]

Estimated Enrollment: 100
Study Start Date: November 2015
Estimated Study Completion Date: November 2026
Estimated Primary Completion Date: November 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02309632

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Kent D McKelvey, MD University of Arkansas
  More Information

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02309632     History of Changes
Other Study ID Numbers: 203640
Study First Received: December 3, 2014
Last Updated: June 12, 2017

Additional relevant MeSH terms:
Syndrome
Neoplasms
Pancreatic Neoplasms
Pancreatitis
Melanoma
Colorectal Neoplasms
Telangiectasis
Ataxia Telangiectasia
Pancreatitis, Chronic
Colorectal Neoplasms, Hereditary Nonpolyposis
Dysplastic Nevus Syndrome
Peutz-Jeghers Syndrome
Disease
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Colonic Diseases

ClinicalTrials.gov processed this record on June 23, 2017