Diagnóstico imunológico colorretal (CiDx): triagem avançada e tratamento personalizado para a saúde do câncer colorretal

The CiDx project develops a novel type of colorectal cancer blood test, the first test to measure the immune response to colorectal development. CiDx is dedicated to developing a cutting-edge, immune-based blood test that leverages bioorthogonal chemistry and machine learning to revolutionize the detection and treatment of CRC. We have already achieved analytical and clinical validation, and was managed to detect CRC with 100% accuracy for 100% sensitivity at 100% specificity in our pilot study (Figure 6). With the proposed project, we will validate CiDx in a wider population, to enhance early-stage cancer detection and prevention, and precision treatment while contributing to the CRC screening program in Portugal. Primary Objective: The foremost goal is to generate evidence on the performance characteristics of CiDx and to provide an acceptable, effective, equitable and cost-effective screening tool, to be evaluated in a subsequent Randomised Controlled Trial (RCT). In addition, CiDx could also monitor the CRC progression, and guide treatment selection via predicting treatment response. The main research question of CiDx is to address the hypothesis that: CiDx can predict CRC at even early-stage and can predict treatment response. To achieve the main objective, we will meet several specific objectives: Objectives (one/ Task): O1: Validation of CiDx in CRC detection. - Individual patient recruitment through CARE platform, in collaboration with Hospital da Luz Lisboa and Hospital de Santa Maria. - Clinical information will be collected, reviewed, and updated in RedCap. O2: Optimize the sensitivity or specificity of CiDx in CRC screening. - Measured protein cross-sections signatures. - Machine learning classifiers will be established to evaluate sensitivity, specificity, positive predictive value and false discovery rate. O3: Predict treatment response by following CRC patients with CiDx. - Follow-up of recruited individuals. - Map transitions between carcinoma in situ, early-stage and late-stage cancer via measuring protein cross-sections signatures longitudinally to track and assess CRC progression. O4: Identify the correlation between protein cross-sections signatures and gut microbiome. - Shotgun metagenomics sequencing. - By discovering the relationship between CiDx in blood and the composition of the gut microbiota, we will be able to: 1) improve the performance of our CRC screening tool; 2) discover the underlying mechanism between the systemic immune response and gut microbiota in CRC. O5. Address public benefit and disseminate the results. - Raising public awareness for early-stage cancer diagnostics and provide relevant information for potential early adopters of our technology. The success of the CiDx project will be measured by the assay’s sensitivity and specificity in detecting CRC, its predictive accuracy for treatment responses, and its adoption rate in clinical settings. By achieving these objectives, CiDx will significantly contribute to reducing CRC mortality rates, improving patient quality of life, and lowering healthcare costs through early detection and personalized treatment strategies.