Clinical trial NCT03218423: Longitudinal Performance of Epi proColon
Official title: Performance of Epi proColon in Repeated Testing in the Intended Use Population (PERT)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Colorectal Neoplasms
Keywords: screening
plasma
DNA methylation
Lead sponsor: Epigenomics, Inc
Sponsor class: INDUSTRY
First posted: 2017-07-14
Enrollment: 4500
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be the population defined in the intended use statement, i.e. adults of either sex, 50 years or older, defined as average risk for CRC, who have been offered and have a history of not completing CRC screening. Tests that are available and recommended in the USPSTF 2008 CRC screening guidelines will be offered and declined prior to offering the Epi proColon test.

Eligible subjects will be recruited at a regular visit at their primary health care provider, or through typical preventive care outreach by health care providers. Consented subjects who agree to participate in the study and agree to be tested with Epi proColon will be enrolled.

Brief summary: This study will evaluate longitudinal performance of Epi proColon with respect to test positivity, longitudinal adherence to Epi proColon screening, adherence to follow-up colonoscopy and diagnostic yield, as well as assay failure rates.

Detailed description: Epi proColon is blood based screening test for colorectal cancer that is FDA - PMA approved. It is indicated for average risk patients who are unwilling or unable to be screened with other recommended screening tests, including colonoscopy or fecal occult blood tests.

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.

Eligibility criteria: Inclusion Criteria:

* Average-risk subjects (no family history of colorectal cancer (CRC), no personal history of polyps or CRC).
* 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 defined as having elevated risk for developing CRC based on previous history of colorectal polyps, CRC or related cancers, inflammatory bowel disease (IBD).
* 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.

Primary outcomes:
measure: The difference in test specificity between initial testing and repeat testing 1 year
timeFrame: Through study completion, expected at 60 months
measure: Detection of colorectal cancer
timeFrame: Through study completion, expected at 60 months
Secondary outcomes:
measure: Adherence to testing
timeFrame: Through study completion, expected at 60 months
measure: Adherence to colonoscopy
timeFrame: Through study completion, expected at 60 months
measure: Diagnostic Yield
timeFrame: Through study completion, expected at 60 months
measure: Assay Failure Rate
timeFrame: Through study completion, expected at 60 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Veterans Affairs San Diego Healthcare System
state: California
city: Royal Oak
country: United States
facility: Beaumont Health System
state: Michigan
city: New Brunswick
country: United States
facility: Rutgers University Hospital
state: New Jersey
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: Epigenomics, Inc
name: Theo deVos, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.