Further Clinical Research Will ‘Push the Needle Forward’ for and Encourage Clinical Adoption ctDNA in Colorectal Cancer


An expert from Natera describes where future research needs to be focused for circulating tumor DNA testing in patients with colorectal cancer following the CIRCULATE-Japan study.

Additional clinical research findings on circulating tumor DNA (ctDNA) as a biomarker for patients with colorectal cancer (CRC) could better support guidelines and lead to a wider scale adoption of the strategy in practice, according to according to Minetta Liu, MD.

In an interview with CancerNetwork®, Liu, chief medical officer of oncology at Natera, discussed how the additional findings could help to support treatment de-escalation in the population and push the needle forward for patients and providers, alike.

Additionally, Liu spoke to the patient demographics of the CIRCULATE-Japan study and highlighted similarities within the United States population. She also touched on similar ongoing studies taking place in the United States assessing ctDNA for cohorts of patients with CRC.


We really need to demonstrate clinical utility. We have strong suggestions from [the GALAXY] observational cohort, and that's really the potential for impact in clinical practice. But to really support guidelines and true clinical adoption for all of these patients and hopefully de-escalate chemotherapy in patients, we need to demonstrate this in clinical utility trials. Those are ongoing. Support for those trials, both in Japan and the U.S where these studies are ongoing, is really what's going to push the needle forward for patients and our providers.

[CIRCULATE-Japan] was performed only in Japan, but the demographics of that patient population are roughly comparable to the United States population. We do have the BESPOKE CRC study [NCT04264702], an observational registry study in the United States. These findings, again, which are following usual care and physician's choice, will help corroborate the observational findings from GALAXY. And then we have parallel, prospective, randomized phase 3 trials for clinical utility in both populations: CIRCULATE-Japan and CIRCULATE-US.


Kotani D, Oki E, Nakamura Y, et al. Molecular residual disease and efficacy of adjuvant chemotherapy in patients with clinical stage II-IV resectable colorectal cancer. Nature Medicine. Published online January 16, 2023. doi:10.1038/s41591-022-02115-4

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