The CRC-PREVENT trial examining the ColonoSight test in colorectal cancer and advanced adenomas has completed enrollment with a diverse patient population.
Enrollment has been completed for the CRC-PREVENT pivotal trial (NCT04739722) evaluating the ColonoSight test to detect colorectal cancer (CRC) and advanced adenomas in average-risk individuals, according to a press release from Geneoscopy Inc.1
The ColonoSight test is a multi-target stool RNA test for colorectal screening. Within the study, more than 14,000 individuals across the United States and of various genders, races, ethnicities, socioeconomic statuses, and geographies, have been enrolled through a decentralized recruitment strategy.
Trial Name: Clinical Validation of the ColonoSight Test: a Multi-target Stool RNA (Mt-sRNA) Assay for Colorectal Neoplasia Screening in Average-risk Individuals Aged >45 Years Old
ClinicalTrials.gov Indentifier: NCT04739722
Recruitment Status: Recruiting
Sponsor: Geneoscopy, Inc.
Contacts: Erica Barnell, PhD, 314-713-5102 erica.barnell@geneoscopy.com, Andrew Barnell, MBA, 314-795-3265 andrew.barnell@geneoscopy.com
A majority of those enrolled in the study come from traditionally under-represented communities, including the Black community.
"Too often, underserved communities face barriers that exclude them from participating in important clinical trials. Our decentralized recruitment strategy helped mitigate these challenges, resulting in a diverse group of participants that are representative of the individuals that may use our noninvasive CRC screening tool," said Erica Barnell, MD, chief science officer and co-founder of Geneoscopy, in a press release.
This prospective, interventional study aims to examine the ColonoSight test and enrolled patients who are eligible for a colonoscopy. To be enrolled, patients must be asymptomatic, average-risk individuals, aged 45 years and older, not up-to-date with screening guidelines, and willing to provide stool samples within 120 days prior to a colonoscopy procedure.2
Stool samples will be subjected to the ColonoSight test system in order to gain results and will be compared to an optical colonoscopy to determine the sensitivity for colorectal cancer, advanced adenomas, and other precancerous adenomas and specificity for hyperplastic polyps and no findings on a colonoscopy.
Over a quarter of participants enrolled in the trial are racial or ethnic minorities with 16% Black or African American, 3% Asian, and 7% Hispanic or Latino. All participants will be evaluated with the Colonosight Test system and a colonoscopy.
Those who have had any precancerous findings on their most recent colonoscopy, a history or diagnosis of colorectal cancer, aerodigestive tract cancer, have had a positive non-invasive screening diagnostic within the associated recommended intervals, had a colonoscopy within the past 9 years, or have had a prior colorectal resection are ineligible for enrollment.
Primary end points of the trial are ColonoSight sensitivity for subjects with CRC, advanced adenoma, high-grade dysplasia, other adenomas, and ColonoSight specificity for subjects with negative findings.
The complete efficacy and enrollment results from the study will be presented later this year and these findings will support a pre-market approval application to the FDA by the end of 2022.
"We were particularly encouraged to see a substantial number of Black participants in our trial. Unfortunately, these individuals have a greater chance of having and dying from CRC compared with other racial groups, and yet too often, are underrepresented in clinical research. We believe that basing advances in cancer screening and prevention on data from all Americans will build greater confidence in new screening tests and, ultimately, save more lives."
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