The study demonstrated that patients who test positive for ctDNA “actually benefit from chemotherapy.”
The CIRCULATE study, a randomized trial involving more than 2,100 patients, has demonstrated that testing for circulating tumor DNA (ctDNA) can improve treatment decisions for colon cancer. Published in Annals of Oncology, the research confirms that ctDNA is a significant risk marker and that patients testing positive for these DNA fragments benefit from chemotherapy.
The trial, conducted between 2020 and 2025 in Germany and Austria, specifically investigated whether patients with detectable ctDNA after surgery benefit from adjuvant treatment. The results confirmed the prognostic value of the biomarker: three years after surgery, 87% of ctDNA-negative patients remained free of recurrence, compared with 52% in the ctDNA-positive group.
“This study provides two key findings,” says Gunnar Folprecht, oncologist and senior physician at Medical Clinic I of Dresden University Hospital, in a release. “We were able to confirm that ctDNA is a clinically significant risk marker. More importantly, we demonstrated that patients who test positive for ctDNA actually benefit from chemotherapy.”
Therapeutic Impact of ctDNA Testing
The study demonstrated a concrete therapeutic effect. Among the patients who tested positive for ctDNA and received treatment, the three-year relapse-free survival rate was 77% with chemotherapy, compared with 38% for those who did not receive treatment. This indicates a significant reduction in the risk of recurrence for the treated group.
These findings suggest that patients without detectable ctDNA may be able to forgo chemotherapy, while those with positive results should receive targeted treatment to improve long-term outcomes.
“To ensure long-term treatment success in patients with colon cancer, chemotherapy tailored to the individual risk of relapse after surgery is also significant,” says Jürgen Weitz, MD, director of the department of visceral, thoracic, and vascular surgery at the University Hospital Dresden, in a release.
Translational Research and Clinical Implementation
The CIRCULATE study highlights the role of translational oncology in moving molecular insights into clinical evidence, the authors note.
“The CIRCULATE study is an impressive example of how translational research transforms molecular insights into clinically useful evidence,” says Esther Troost, dean of the faculty of medicine at TUD Dresden University of Technology, in a release.
However, several obstacles remain before widespread clinical adoption. The specific test used in the study is not yet commercially available. While other commercial alternatives exist (such as Guardant’s Shield CRC blood test), the costs are not currently covered by statutory health insurance providers in Germany.
“Before ctDNA-based treatment decisions can become part of everyday clinical practice, issues regarding availability and financing need to be resolved,” says Folprecht in a release.
The study was designed at Dresden University Hospital and funded by the German Federal Ministry of Research, Technology, and Space. It involved more than 140 study centers, including the German Society for Medical Oncology, the Austrian Breast & Colorectal Cancer Study Group, and Ruhr University Bochum.
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