Trial for At-Home Colorectal Cancer Test Completes Enrollment of More Than 10,000 Patients

Many participants enrolled in the CRC-PREVENT trial are from communities often underrepresented in clinical trials due to gender, race and socioeconomic status, among other factors.

Researchers conducting a trial to evaluate a noninvasive at-home diagnostic test for colorectal cancer completed enrollment of participants including those belonging to traditionally underrepresented communities, according to a press release.

In particular, the CRC-PREVENT trial will include more than 14,000 participants across 48 states in the U.S, according to the test’s manufacturer, Geneoscopy. Researchers focused on enrolling many participants from communities that are traditionally underrepresented in clinical trials by way of gender, race, ethnicity, socioeconomic status and geography.

“Too often, underserved communities face barriers that exclude them from participating in important clinical trials,” said Dr. Erica Barnell, chief science officer and co-founder of Geneoscopy, in the release. “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 (colorectal cancer) screening tool.”

Sixteen percent of participants of the CRC-PREVENT trial are Black or African American. For context, only about 5% of clinical trial participants are Black and 12% of the U.S. population is Black or African American, according to the release. Additionally, 3% of participants in this current trial are Asian and 7% are Latino.

“We were particularly encouraged to see a substantial number of Black participants in our trial,” Barnell added in the release. “Unfortunately, these individuals have a greater chance of having and dying from (colorectal cancer) 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.”

Findings from the CRC-PREVENT trial will be presented later this year, according to the release. These findings will be used for an application to the U.S. Food and Drug Administration for potential approval by the end of 2022.

According to the American Cancer Society, colorectal cancer affects patients who are Black more than any other racial or ethnic group in the U.S. Compared to other groups, patients who are Black are 20% more likely to be diagnosed with colorectal cancer and 40% more likely to die from it.

Colorectal cancer is the second leading cause of cancer death in the U.S., with over 50,000 deaths annually, according to the release. Early detection and treatment are important to improve a patient’s survival. Colonoscopy is currently the gold standard for screening for colorectal cancer; however, patients are often hesitant to undergo the procedure due to its preparation, sedation and discomfort. This highlights the need for another noninvasive option to potentially improve patient compliance to screening protocols.

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