Exosome-based Detection of Molecular Residual Disease in Stage II-III Colorectal Cancer

The current standard for treating stage II-III colorectal cancer involves surgical resection, often followed by adjuvant chemotherapy (ACT) for high-risk patients. However, identifying patients who would benefit most from ACT remains challenging. Molecular residual disease (MRD) in these patients is a critical factor in determining the likelihood of recurrence. This study aims to develop an exosome-based liquid biopsy assay using circulating exosomal microRNAs (exo-miRNAs) to predict the presence of MRD in postoperative patients. By analyzing exo-miRNAs from blood samples collected after surgery, the goal is to identify high-risk patients who may benefit from ACT while sparing low-risk patients from unnecessary treatment. A risk-stratification model, termed the exosome-based molecular residual disease prediction for adjuvant chemotherapy induction (EMRATI) score, will be developed to improve ACT decision-making and enhance clinical outcomes for stage II-III CRC patients.

Inclusion criteria

• Patients with pathologically confirmed stage II or III colorectal cancer.
• Patients who have undergone curative-intent surgery.
• Patients with no evidence of distant metastasis (stage IV).
• Patients aged 18 years or older.
• Patients who provided written informed consent.

Exclusion criteria

• Patients with stage IV cancer or those receiving neoadjuvant therapy.
• Patients with non-curative resection or requiring urgent surgery.
• Patients with a follow-up period of fewer than 3 years.
• Patients with severe comorbidities or who are unable to participate in follow-up assessments.