Abstract P12: Application of Novel Immune Signatures for the Early Detection of Colorectal Cancer

Abstract Background & Aims: Colorectal cancer (CRC) is one of the most common and deadly cancers worldwide. Here we aim to identify and develop novel diagnostic biomarkers to detect early-stage CRC. Methods: Candidate biomarkers were identified from RNA-seq, validated using RT-qPCR essays and developed through the bioinformatics pipeline using multivariate binary logistic regression and receiver operating characteristic curve analysis. Results: We identified a novel 2-gene signature within blood leukocytes which could robustly discriminate CRC from healthy controls (HC). Using an RT-qPCR assay based on the 2-gene signature, we detected CRC samples from HC samples with a sensitivity of 80% and a specificity of 81% in a training retrospective cohort of 314 samples and derived a logistic equation to calculate CRC risk probability termed as HIR-CRC. In an independent cohort of 178 samples, we validated 2-gene test and detected CRC from HC with a sensitivity of 82% and a specificity of 78%. Importantly, the 2-gene test can detect early-stage CRC and CRC which are tested negative for carcinoembryonic antigen (CEA) and carbohydrate antigen 19-9 (CA19-9) with 76-88% sensitivity which is significantly higher than that of either CEA (31-56%) or CA19-9 (9-44%). Conclusion: The 2-gene signature described here can potentially fill an unmet clinical need for a robust screening assay to identify CRC patients at early stages when potentially curative treatment options are available. Citation Format: Yu Wang, Jinli Zhao, Heng Dong, Wei Wang, Yong Zeng, Jianxiang Chen. Application of Novel Immune Signatures for the Early Detection of Colorectal Cancer [abstract]. In: Proceedings of Frontiers in Cancer Science 2024; 2024 Nov 13-15; Singapore. Philadelphia (PA): AACR; Cancer Res 2025;85(15_Suppl):Abstract nr P12.