A new method to triage colorectal cancer referrals using serum Raman spectroscopy and machine learning

Suspected colorectal cancer (CRC) referrals based on non-specific symptoms currently lead to large numbers of patients being referred for invasive investigations and poor yield in cancer detection. Secondary care diagnostics, particularly endoscopy, struggle to meet the ever-increasing demand and patients face lengthy waits from the point of referral. Here we propose a blood test utilising high-throughput Raman spectroscopy and machine learning as an accurate triage tool. We present results from the first mixed methods clinical validation study of its kind, evaluating the ability of the test to perform in its target population of primary care patients, and its acceptability to those administering and receiving the test. The test was able to accurately rule out cancer with a negative predictive value of 98.0%. This performance could reduce the number of invasive diagnostic procedures in the cohort by at least 47%. Collectively, our findings promote a novel, non-invasive solution to triage CRC referrals with potential to reduce patient anxiety, accelerate access to treatment and improve outcomes. ### Competing Interest Statement PRD, DAH and CAJ declare that they are all co-founders and managing directors of CanSense Ltd, an incorporated cancer diagnosis spin-out company from Swansea University (UK company no: 11367637). All other authors declare no competing interests. ### Clinical Trial IRAS 146942 ### Funding Statement This study was funded through a Welsh Government Efficiency Through Technology Fund (X.481.HTT). This work was also supported through Cancer Research Wales: Raman spectroscopy and Colorectal cancer: Transforming the USC referral pathway (Registered Charitable Incorporated Organisation Number: 1167290). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Wales REC 6 All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes The datasets generated and/or analysed during the current study are available within the article and supplementary information files and available from the authors upon reasonable request.