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Cancer

Circulating Tumor DNA May Improve Outcomes for Locally Recurrent Rectal Cancer Patients

Strategic Insights

— 1 min read

Researchers from the National Cancer Center Hospital in Tokyo, Japan, have launched a multi-institutional prospective observational study to investigate the utility of circulating tumor DNA (ctDNA) in detecting minimal residual disease (MRD) in patients with locally recurrent rectal cancer. The study aims to identify reliable prognostic and predictive biomarkers to guide treatment decisions and improve outcomes. According to the research protocol, patients will provide whole blood samples at various time points, and cell-free DNA will be extracted and analyzed to determine the presence or absence of ctDNA.

Key Takeaways:

  • The study is a multi-institutional, prospective observational study that aims to investigate the utility of ctDNA in detecting MRD in patients with locally recurrent rectal cancer.
  • The study will involve patients who are enrolled in the JCOG1801 trial, a randomized, controlled phase III trial that compares the efficacy of preoperative chemoradiotherapy (pre-CRT) with up-front surgery for locally recurrent rectal cancer.
  • Patients will provide whole blood samples at three time points (prior to surgery, after surgery, and after postoperative chemotherapy) if they are randomized to up-front surgery, and at five time points (prior to pre-CRT, after pre-CRT, prior to surgery, after surgery, and after postoperative chemotherapy) if they are randomized to pre-CRT.
  • Cell-free DNA will be extracted from plasma and analyzed using the Guardant Reveal assay, which assesses both genomic alterations and methylation patterns to determine the presence or absence of ctDNA.
  • The study will compare the prognosis and treatment response of patients according to their ctDNA status after surgery and at other time points.

Statistics:

  • The study will enroll patients from multiple institutions, including the National Cancer Center Hospital East.
  • The Institutional Review Board of the National Cancer Center Hospital East approved the study protocol in February 2023.
  • The study is conducted in accordance with the Declaration of Helsinki and Ethical Guidelines for Medical and Biological Research Involving Human Subjects.
  • Written informed consent will be obtained from all eligible patients prior to registration.

Sources:

  • Utility of circulating tumour DNA for prognosis and prediction of therapeutic effect in locally recurrent rectal cancer: study protocol for a multi-institutional, prospective observational study (JCOG1801A1, CAP-LR study). BMJ Open, 2023,13(8). (BMJ Open - http://bmjopen.bmj.com/).
  • The publisher for BMJ Open is BMJ Publishing Group.
  • A free version of this journal article is available at https://doi-org.sdpl.idm.oclc.org/10.1136/bmjopen-2023-073217.

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