Study Results
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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UNKNOWN
4500 participants
OBSERVATIONAL
2017-08-18
2024-01-31
Brief Summary
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Detailed Description
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The PERT study is designed to assess the test performance of Epi proColon when it is used annually for two consecutive years. Subjects enrolled in the study will be offered initial testing. Subjects with a positive result will be referred for colonoscopy. Subjects with a negative test result will be encouraged to be screened the following year. At the one year interval, test negative subjects will be reminded to be rescreened. Subjects with a positive test will be referred for colonoscopy, while subjects with a negative test will be be encouraged to participate in a screening program in subsequent years.
Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Interventions
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Epi proColon
Plasma cell free DNA SEPT9 promoter methylation test for colorectal cancer screening.
Eligibility Criteria
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Inclusion Criteria
* Subjects who have a history of non-compliance for CRC screening.
* After proper counseling by a health care provider, subjects who declined colonoscopy and FIT testing.
* Subjects who are 50 years of age or greater, but less than 75 years old.
* Subjects who are able to understand and sign written informed consent (IC).
Exclusion Criteria
* Subjects with a family history of CRC, particularly with two or more first degree relatives with CRC, or one or more first degree relative(s) less than 50 years of age with CRC.
* Subjects who have been diagnosed with a relevant familial (hereditary) cancer syndrome, such as familial adenomatous polyposis (FAP) or non-polyposis colorectal cancer (HNPCC or Lynch Syndrome), Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's syndrome, Turcot's (or Crail's) syndrome, Cowden's syndrome, Juvenile Polyposis, Cronkhite-Canada syndrome, Neurofibromatosis, or Familial Hyperplastic Polyposis, or in patients with anorectal bleeding, hematochezia, or with known iron deficiency anemia.
* Subjects who are up to date for CRC screening (FOBT within preceding 12 months, flexible sigmoidoscopy or double contrast barium enema within 5 years, or colonoscopy within 10 years).
* Subjects with comorbid illness precluding endoscopic evaluation (coronary artery disease with myocardial infarction within 6 months, unstable angina or congestive heart failure, chronic obstructive pulmonary disease requiring home oxygen, other diseases that limit life expectancy to less than 10 years).
* Subjects with chronic gastritis, or who have cancer other than colorectal, or pregnant women.
50 Years
74 Years
ALL
Yes
Sponsors
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Epigenomics, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Theo deVos, PhD
Role: STUDY_DIRECTOR
Epigenomics, Inc
Locations
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Veterans Affairs San Diego Healthcare System
San Diego, California, United States
Beaumont Health System
Royal Oak, Michigan, United States
Rutgers University Hospital
New Brunswick, New Jersey, United States
Duke University
Durham, North Carolina, United States
Geisinger Health System
Danville, Pennsylvania, United States
West Virginia University
Morgantown, West Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Debora Goodman
Role: primary
Karen Barger-Smith
Role: primary
Maureen Cooney
Role: backup
Marie Macor
Role: primary
Kim Leathers
Role: primary
Kathy Chmielewski
Role: backup
Kay Reiner, MPH, BSN, RN
Role: primary
Elyse Krupp
Role: primary
References
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Potter NT, Hurban P, White MN, Whitlock KD, Lofton-Day CE, Tetzner R, Koenig T, Quigley NB, Weiss G. Validation of a real-time PCR-based qualitative assay for the detection of methylated SEPT9 DNA in human plasma. Clin Chem. 2014 Sep;60(9):1183-91. doi: 10.1373/clinchem.2013.221044. Epub 2014 Jun 17.
Johnson DA, Barclay RL, Mergener K, Weiss G, Konig T, Beck J, Potter NT. Plasma Septin9 versus fecal immunochemical testing for colorectal cancer screening: a prospective multicenter study. PLoS One. 2014 Jun 5;9(6):e98238. doi: 10.1371/journal.pone.0098238. eCollection 2014.
Related Links
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FDA Epi proColon product page
Other Identifiers
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SPR 0028
Identifier Type: -
Identifier Source: org_study_id