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Pancreatic Cancer Screening of High-Risk Individuals in Arkansas

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ClinicalTrials.gov Identifier: NCT02309632
Recruitment Status : Withdrawn (Lack of funding)
First Posted : December 5, 2014
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Pancreatic Cancer Screening of High-Risk Individuals in Arkansas
Estimated Study Start Date : November 2015
Actual Primary Completion Date : July 19, 2019
Actual Study Completion Date : July 19, 2019


Arm Intervention/treatment
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




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


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309632


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

Additional Information:

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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02309632     History of Changes
Other Study ID Numbers: 203640
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Colorectal Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Neoplastic Syndromes, Hereditary
Melanoma
Dysplastic Nevus Syndrome
Peutz-Jeghers Syndrome
Pancreatitis
Pancreatitis, Chronic
Ataxia Telangiectasia
Telangiectasis
Syndrome
Disease
Pathologic Processes
Nevi and Melanomas
Digestive System Diseases
Endocrine System Diseases
Ataxia