US-based cell-free DNA testing company Natera has started enrolment for two clinical trials, dubbed CIRCULATE-Japan and BESPOKE CRC, to measure clinical outcomes of Signatera molecular residual disease (MRD) testing for resectable stages II-IV colorectal cancer (CRC).

The CIRCULATE-Japan is a prospective, multi-centre, randomised clinical trial that evaluates optimal circulating tumour DNA (ctDNA)-guided treatment strategies for patients with CRC, specifically for adjuvant chemotherapy decisions based on MRD status.

The study that enrols 2,500 patients from around 150 cancer centres is organised by the National Cancer Center (NCC) Japan.

Principal investigator of the study Takayuki Yoshino said: “We are encouraged to see the trial gaining so much early momentum, and we see a great opportunity ahead to improve treatment decisions for the thousands of CRC patients in Japan, and worldwide, who may not benefit from adjuvant chemotherapy.

“We are pleased to be working with Natera, whose personalized, tumor-informed ctDNA technology will allow us to more accurately estimate the risk of recurrence after surgery, as well as detect recurrence earlier for novel intervention.”

Signatera is a ctDNA test for monitoring treatment and MRD assessment in cancer patients

BESPOKE CRC is a multi-centre clinical trial designed to enrol more than 1,000 patients to measure the clinical impact of serial blood-based testing with Signatera, earlier relapse detection, and better patient risk stratification after surgery.

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer.

The test received the FDA Breakthrough Device Designation in 2019 and is available for clinical and research use.

Signatera test is personalised and tumour-informed, providing individuals with customised blood test, for unique signature of clonal mutations found in that individual’s tumour.

Natera senior medical director Alexey Aleshin said: “The breadth of interest in both trials is exceptional. We believe this momentum reflects a clear global unmet need for better recurrence monitoring tools in colorectal cancer and a growing consensus around Signatera’s personalized technology as the right diagnostic approach.”