Abstract 2296: A multicenter, prospective evaluation of urine-based ctDNA assay for urinary cancers diagnosis

• DOI: 10.1158/1538-7445.am2020-2296
• Publication Date: 2020-09-04T01:35:01Z
• Authors: Hu Qu; Yu Zeng; Yan Li; Youyan Guan; Jianhe Liu; Kewen Zheng; Jia Lyu; Xiaoyan Zhang; Le Li; Jiao Feng; Yiming Liang; Tonghui Ma
• Keywords: 6. Clean water; 3. Good health

Abstract Background: There is still some limitations for the diagnosis of urinary cancers, such as invasiveness cystoscopy and ureteroscopy, requirements experienced experts in interpreting images, low sensitivity cytology FISH, great economic pressure long-term monitoring, etc. Thus, there an urgent need accurate, less-expensive, non-invasive method cancers. Previously, A Genetron Urinary Assay were developed, which showed good performances upper urothelial cancer bladder cancer. In following, a prospective, multicenter study was conducted to evaluate clinical performance this assay on patients with diseases. Materials Methods: From October 2018 2019, 120 underwent hematuria enrolled before any treatment. The pathological all completed by urologists from eight hospitals China. urine samples collected or DNA extracted cell pellets. Assay, including multiplex PCR-based next generation sequencing 17 genes detection methylation levels CpG-sites located ONECUT2 gene, used. For statistical analysis, either mutation detected gene (at least one mutated) lower ΔCt value methylated (≤7.6) considered positive. Results: Data 109 available analysis. Among them, 78 males 31 females, their average age 61.5. Based features rigorous diagnosis, 74 cases diseases, 32 tract 3 multifocal According results cystoscopy, ureteroscopy pathology, 79 (72.5%) confirmed malignant tumors 30 benign. that pathologically diagnosed malignant, our 66 positive 13 negative. And benign samples, numbers positives negatives 27. these data, overall sensitivity, specificity, negative predictive (NPV) (PPV) 83.5%, 90.0%, 67.5%, 95.7%, respectively. Conclusion: This shows liquid biopsy has It advantages non-invasiveness, low-cost, high so it worth expecting supplement even replace traditional diagnostic techniques. Citation Format: Hu Qu, Yu Zeng, Yan Li, Youyan Guan, Jianhe Liu, Kewen Zheng, Jia Lyu, Xiaoyan Zhang, Le Jiao Feng, Yiming Liang, Tonghui Ma. multicenter, prospective evaluation urine-based ctDNA cancers [abstract]. In: Proceedings Annual Meeting American Association Cancer Research 2020; 2020 Apr 27-28 Jun 22-24. Philadelphia (PA): AACR; Res 2020;80(16 Suppl):Abstract nr 2296.