Abstract
BACKGROUND AND AIMS: Colorectal cancer (CRC) typically develops over 10-15 years, providing a critical window for early detection and prevention. Precursor lesions, including neoplastic (adenomatous) and non-neoplastic (hyperplastic) polyps, can be detected via colonoscopy, which remains the only current modality capable of identifying precancerous lesions. However, colonoscopy is limited by its invasiveness, cost, and accessibility. This study evaluates CancerenD24, a simple blood-based assay measuring cluster of differentiation 24 (CD24) expression, for its ability to distinguish healthy individuals from those with adenomas or CRC. METHODS: A total of 652 participants were enrolled at Tel Aviv Medical Center: 505 healthy controls, 22 with hyperplastic polyps, 25 with adenomatous polyps, and 100 with CRC. Healthy individuals underwent full screening, including colonoscopy, at the Integrated Cancer Prevention Center. Adenoma and CRC patients were recruited from gastroenterology, surgery, and oncology departments. CD24 expression was assessed by staining 10(6) leukocytes with anti-cluster of differentiation 11b/anti-CD24 antibodies, followed by flow cytometry. Data were integrated into the Pan-cancer Screening Probability Index, incorporating epidemiologic and laboratory parameters. The study was conducted under good laboratory practice and approved by the local institutional review board and Ministry of Health. RESULTS: Mean CancerenD24 scores were significantly lower in healthy individuals (0.11 ± 0.01) compared to those with adenomas (0.26 ± 0.04) or CRC (0.45 ± 0.03), correlating with polyp size and histology. No gender-based differences were observed. CONCLUSION: CD24 levels increase early in CRC carcinogenesis, detectable already at the level of adenomas >5 mm. CancerenD24, as a noninvasive screening tool, shows promise as an aid to clinicians in identifying at-risk individuals and may reduce reliance on colonoscopy. Further validation is ongoing.