Skip to main content
Premium Trial:

Request an Annual Quote

Natera, French Hospitals Partner on Phase III Colorectal Cancer Precision Treatment Study

NEW YORK – Natera announced Monday that it teamed up with two French hospitals to support an ongoing randomized Phase III trial studying molecular residual disease (MRD)-guided adjuvant treatment in stage II colorectal cancer (CRC) patients.

The Fédération Francophone de Cancérologie Digestive and Centre Hospitalier Universitaire Dijon, Bourgogne, selected Natera to participate in the CIRCULATE-PRODIGE-70 trial, which launched in 2020 and is complementary to the CIRCULATE-Japan and CIRCULATE-US trials. 

While those studies focused on evaluating the benefit of MRD-guided treatment in stage III and high-risk stage II CRC patients, the French trial is assessing the benefit of adjuvant chemotherapy (ACT) in stage II CRC patients with detectable circulating tumor DNA (ctDNA) post-surgery.

Patients who are MRD-positive by Signatera in the French study will either receive a combination ACT therapy of oxaliplatin, 5-fluorouracil, and leucovorin (FOLFOX 6m) or will undergo observation only. Patients who are MRD-negative will receive the standard-of-care treatment, which is observation.

Austin, Texas-based Natera expects to test approximately 1,600 trial participants with Signatera in the hope of gaining adoption and reimbursement of its flagship MRD test in France. The initial trial readout is expected in 2025.

"We are pleased to have been selected to support this pivotal trial, which underscores the value of personalized MRD testing across various clinical settings in colorectal cancer," Adham Jurdi, senior medical director of oncology at Natera, said in a statement.

Earlier this year, Natera presented evidence at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium that serial MRD testing picks up more patients with emerging ctDNA than tests performed at an initial landmark time point, and that ACT can clear ctDNA, sometimes for sustained periods of time.