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Guardant Health, Royal Marsden Partner on Prospective Liquid Biopsy Trial in Early Colorectal Cancer

NEW YORK – Guardant Health said on Thursday that it is partnering with the Royal Marsden NHS Foundation Trust on part C of its TRACC (Tracking mutations in cell-free DNA to predict Relapse in eArly Colorectal Cancer) study, which will evaluate the use of circulating tumor DNA to guide chemotherapy treatment decisions after curative-intent surgery in patients with early-stage colorectal cancer.

The multicenter, prospective, randomized trial is intended to assess whether the company's Guardant Reveal assay can accurately identify patients that can be spared unnecessary chemotherapy and its associated side effects based on a negative blood test result after their tumor is removed surgically.

Patients with high-risk stage II and stage III colorectal cancer are routinely offered chemotherapy after surgery to help reduce their risk of relapse from microscopic minimal residual disease. But research has shown that up to 80 percent of these patients may be cured by their surgery alone, receiving no benefit from adjuvant chemotherapy.

"Patients with high-risk colorectal cancer are often overtreated and can suffer long-term neurotoxicity from chemotherapy," said Royal Marsden Clinical Director David Cunningham, who will serve as the chief investigator for TRACC Part C.

Guardant said the trial began opening sites in August 2022 and will eventually involve approximately 40 sites across the UK, with a planned recruitment of 1,621 patients over four years. The study is funded by the Efficacy and Mechanism Evaluation Program, which is a partnership between the UK's Medical Research Council and National Institute of Health Research.