Trial in progress for a colorectal cancer detection blood test.

TPS306 Background: Blood-based biomarkers for cancer screening have garnered much anticipation in recent years. Current colorectal cancer screening methodologies such as colonoscopy and stool-based tests are plagued with low compliance rates. While scientific advancement calls for clinical trial recruitment from diverse backgrounds to ensure health equity, traditional clinical trial design has led to the underrepresentation of such populations, resulting in a gap in our understanding of disease conditions, preventative measures, and appropriate treatment across populations. Here, we describe an ongoing, decentralized, prospective sample collection clinical study, PROCEED-CRC, to develop a blood-based CRC screening test in an average-risk population. Methods: The primary endpoint of the study is to achieve the successful enrollment of up to 1500 evaluable patients. Key eligibility criteria include participants aged ≥40 years, planning to undergo an asymptomatic screening colonoscopy, willing to provide a blood sample within 120 days prior to a colonoscopy procedure, and an informed consent prior to participation in the study. Exclusion criteria include individuals who have had a prior malignancy, have undergone diagnostic colonoscopy in the past 9 years, or any other recent CRC screening tests, precancerous findings on recent colonoscopy, or are at high risk for CRC based on germline carrier status. Primary analysis would include summarizing the number and percentage of participants classified to have CRC, advanced adenoma, or non-advanced neoplasia. In order to reach a diverse study cohort that is representative of this average-risk US population aged over 45 years, we implemented several non-traditional recruitment outreach efforts, such as engaging a pharmacy provider to whom individuals may have previously consented to receive messages/notifications. Additional outreach efforts include digital advertisements and referral letters from healthcare professionals and community advocacy groups. Through these efforts, interested participants will have access to a link, a web address, or QR code to be screened for the study. After informed consent and enrollment, participants may schedule a blood draw via a mobile phlebotomy center based on their availability. Participants are considered evaluable if they meet the inclusion criteria, provide informed consent, provide an adequate blood draw, complete the screening colonoscopy within 120 days of the blood draw, and have medical records and pathology reports provided. The data from this study is expected to be completed in May 2025.