COSMOS-CRC-01: Study Design and Methodology

Author(s):

Yoshiaki Nakamura, MD, PhD, discusses how the COSMOS-CRC-01 study was designed to evaluate the efficacy of ctDNA analysis for MRD detection, outlining the rationale for patient enrollment, the timing of plasma sample collection, and the implications for monitoring disease post surgery and during adjuvant chemotherapy.

EP: 1.Risk of Recurrent Colorectal Cancer Following Definitive Therapy

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EP: 2.COSMOS-CRC-01: Study Design and Methodology

EP: 3.COSMOS-CRC-01: Clinicopathologic Correlation of ctDNA With RFS

EP: 4.COSMOS-CRC-01: Sensitivity and Specificity of a Serial, Cell-Free DNA Epigenomic Platform in Detecting MRD in Real Time

EP: 5.Concluding Remarks for the Current Use of ctDNA Testing for Treatment Decisions in stage II-III CRC

1. Please explain the rationale, enrollment criteria, objectives, and methodology of the COSMOS-CRC-01 study

2. What patient and/or disease factors motivated the decision to obtain the first plasma sample for ctDNA analysis at postoperative day28?

In your experience, how soon after resection for R0 (ie, microscopically margin negative) stage II to III CRC can ctDNA sequencing be conducted and reliably detect potential MRD at the micrometastatic level?

3. Please review the timing of pre-and postadjuvant chemotherapy plasma sampling from patients who received ACT.

In postoperative adjuvant chemotherapy, should the patient complete all cycles before submitting a plasma sample for ctDNA analysis?
- Are there circumstances when a ctDNA sample might be obtained on treatment?