Clinical Validation and Benchmarking of ctDNA Diagnostics for Guiding Multi-Modal Therapies in Colorectal Cancer - GUIDE.MRD-01-CRC

What this Trial Is About

Researchers are evaluating the clinical utility of circulating tumor DNA (ctDNA) diagnostics to improve personalized treatment decisions for colorectal cancer patients. Current methods for deciding post-surgery treatment are not optimal, leading to overtreatment or undertreatment. The GUIDE.MRD consortium, involving experts from science, technology, and pharmaceutical companies, aims to create a reliable standard for ctDNA tests and to collect data to identify the best diagnostic tests for use in colorectal cancer care. This study is part of the larger GUIDE.MRD project focused on validating ctDNA technologies. The study involves collecting clinical samples from patients with stage III colorectal cancer and those with colorectal cancer liver metastasis who have undergone surgery with curative intent. Samples will be analyzed at key time points such as post-surgery, post-adjuvant therapy, during chemotherapy, and through follow-up surveillance. The study will assess and compare the performance of multiple ctDNA diagnostics, measuring sensitivity, specificity, and predictive values to determine which tests best identify residual disease and guide treatment decisions. Participants will provide plasma samples at relevant time points, including up to 8 months after recruitment ends. Researchers will monitor 3-year recurrence-free survival, measure the time between ctDNA detection and clinical recurrence, and evaluate ctDNA's ability to predict response to adjuvant therapy. The study includes assessments over several years to understand long-term outcomes and the potential for ctDNA tests to influence treatment strategies and improve patient management.

GUIDE.MRD-01-CRC: Clinical Validation and Benchmarking of Top Performing ctDNA Diagnostics - Colorectal Cancer