Abstract 65: Point of Care Urine Metabolomics Test to Diagnose Colorectal Cancers in Low- and Middle-Income Countries: A Pilot Controlled Trial in Southwestern Nigeria

Abstract

Abstract Purpose: The incidence of colorectal cancer (CRC) is increasing in LMICs, with patients experiencing poorer outcomes compared to HICs due mainly to lack of screening and late diagnosis. A cost-effective early diagnosis test for CRC could allow earlier-stage diagnosis with better outcomes and may also prevent patients from developing CRC, however such a test is not yet available in Nigeria and other LMICs. This study piloted a Point of Care (POC) real-time urine metabolomics test, to evaluate its validity in diagnosing CRC among at-risk patients and assess the willingness of patients in Southwestern Nigeria to utilize and pay for the test. Methods: A pilot-controlled trial was carried out among 72 patients (34 cases, 38 controls) in southwestern Nigeria. The cases had histopathological diagnosis of CRC while controls were at-risk adults. The POC biosensor uses a disposable chip and can be connected to a smart device using Bluetooth. It reports if the patient’s urine contained metabolites consistent with CRC. We assessed validity of the test using sensitivity, specificity, positive predictive and negative predictive values. We pre- specified a specificity of 50% with a goal of ≥ 80% sensitivity to estimate the potential of the test to half the referrals to colonoscopy. Utilizing structured questionnaires, we assessed perception towards the test and willingness to uptake the urine test. Results: The mean age for cases and controls were 57.06 ± 16.06 and 54.84 ± 13.05 respectively. The overall sensitivity, specificity, positive predictive and negative predictive values for all respondents were 91.18%, 81.58%, 81.58% and 91.18% respectively, with an area under the ROC curve of 0.86. With specificity fixed at 50%, overall sensitivity for all respondents was 94.5%, and all stratifications had sensitivity >90%, with the stratification for those with hemorrhoids/anal fissure, hemorrhoids/anal fissure + bloody stool and hemorrhoids/anal fissure + bloody stool + weight loss having a sensitivity of 100%. Overall, 70 (98.6%) were satisfied with the urine-based CRC screening, and respondents were willing to pay a mean amount of 8,008.20 Naira (about $5.2) for the test. Conclusion: We developed and pilot tested a urine metabolite early diagnosis POC test that met our pre- determined criteria for success and had high acceptance rates among Nigerian patients. We are planning a much larger multi-institutional implementation trial to determine if these results can scale up. Citation Format: Adeleye Abiodun Adeomi, Olusegun Alatise, David Wishart, Scott MacKay, Olalekan Olasehinde, Funmilola Wuraola, Adewale Adisa, Tajudeen Mohammed, Adewale Aderounmu, Omolade Adefolabi Betiku, Oluwatosin Zainab Omoyiola, Adeoluwa Oluwaseyi Adeleye, Samson Oluwagbemiga Ogunleye, Olusegun Joshua Babatunde, Oluwabusayomi Roseline Ademakinwa, Israel Adeyemi Owoade, Jacob Mobolaji, Cristina Olcese, Rivka Kahn, Naqiya Rahil Choonawala, Grace Fitzgerald, H. Dean Hosgood, T. Peter Kingham. Point of Care Urine Metabolomics Test to Diagnose Colorectal Cancers in Low- and Middle-Income Countries: A Pilot Controlled Trial in Southwestern Nigeria [abstract]. In: Proceedings of the 13th Annual Symposium on Global Cancer Research; 2025 Sep 16. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2025;34(12_Suppl):Abstract nr 65.