Longitudinal Performance of Epi proColon

Colorectal Cancer Clinical Trial

— PERT  

Official title:

Performance of Epi proColon in Repeated Testing in the Intended Use Population (PERT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03218423
• Other study ID #: SPR 0028
• Status: Recruiting
• Start date: August 18, 2017
• Est. completion date: January 2024

Study information

• Verified date: October 2021
• Source: Epigenomics, Inc
• Contact: Theo deVos, PhD
• Phone: 2068832916
• Email: theo.devos[@]epigenomics.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4500
• Est. completion date: January 2024
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Device:
• Epi proColon
Plasma cell free DNA SEPT9 promoter methylation test for colorectal cancer screening.

Locations

Country	Name	City	State
United States	Geisinger Health System	Danville	Pennsylvania
United States	Duke University	Durham	North Carolina
United States	West Virginia University	Morgantown	West Virginia
United States	Rutgers University Hospital	New Brunswick	New Jersey
United States	Beaumont Health System	Royal Oak	Michigan
United States	Veterans Affairs San Diego Healthcare System	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Epigenomics, Inc

Country where clinical trial is conducted

United States, 

References & Publications (2)

Johnson DA, Barclay RL, Mergener K, Weiss G, König 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in test specificity between initial testing and repeat testing 1 year	Subjects will be tested with blood-based Epi proColon assay at initial enrollment, and tested again 1 year later (positive or negative test results); Subjects with positive test results with Epi proColon assay are referred to colonoscopy. Colonoscopy outcomes will be recorded (no evidence of disease or CRC); The difference in test specificity between initial and follow-up visits will be recorded.	Through study completion, expected at 60 months
Primary	Detection of colorectal cancer	Findings of colorectal cancer in subjects with a colonoscopy following a positive Epi proColon test will be recorded.	Through study completion, expected at 60 months
Secondary	Adherence to testing	The adherence to repeated Epi proColon testing by patients who had a negative initial Epi proColon result will be recorded.	Through study completion, expected at 60 months
Secondary	Adherence to colonoscopy	The rate of adherence to colonoscopy for patients with a positive Epi proColon result will be recorded	Through study completion, expected at 60 months
Secondary	Diagnostic Yield	All procedure results will be recorded for patients who complete a colonoscopy evaluation following a positive Epi proColon test	Through study completion, expected at 60 months
Secondary	Assay Failure Rate	The Epi proColon assay failure rate will be recorded during the duration of the study	Through study completion, expected at 60 months

External Links

•   FDA Epi proColon product page