Clinical trial and real-world evidence of circulating tumor DNA monitoring to predict recurrence in patients with resected colorectal cancer

Background: Circulating tumor DNA (ctDNA) is a novel biomarker to predict recurrence in colorectal cancer (CRC). However, clinical validation data in underrepresented patient populations like Southeast Asians are lacking. Materials and methods: In our prospective clinical trial, 92 patients with stage I-IVA CRC and eligible for curative-intent surgery were recruited. Blood samples were collected before surgery, after surgery and during surveillance. ctDNA analysis was carried out using a personalized tumor-informed approach. Performance of ctDNA monitoring was further evaluated in a retrospective analysis of 32 patients who had commercial ctDNA testing. Results: (41.2%), with high frequency of co-mutations. Conclusion: Our analysis from both clinical trial and real-world data indicated that ctDNA was an independent and strong prognostic biomarker to predict recurrence in CRC. ctDNA testing could be helpful for clinical decision making by enabling personalized intervention and surveillance strategies.