An Exosome-Based Liquid Biopsy Assay to Detect Molecular Residual Disease for the Identification of High-Risk Patients With Stage II-III Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Tumor Evaluation (Recurrence)
研究概览
简要总结
This study aims to establish an exosome-based liquid biopsy signature to detect molecular residual disease (MRD) in stage II-III colorectal cancer (CRC) patients. Identifying patients with MRD after surgery is crucial for selecting appropriate candidates for adjuvant chemotherapy (ACT), allowing for more personalized treatment approaches and potentially improving patient outcomes.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Training Cohort (Recurrence Group)
Stage II-III CRC patients who experienced postoperative recurrence (evaluated by miRNA panel).
Training Cohort (Non-Recurrence Group)
Stage II-III CRC patients who did not experience postoperative recurrence (evaluated by miRNA panel).
Testing Cohort (Recurrence Group)
Validation of miRNA panel and EMRATI score in independent stage II-III CRC patients who experienced postoperative recurrence.
Testing Cohort (Non-Recurrence Group)
Validation of miRNA panel and EMRATI score in independent stage II-III CRC patients who did not experience postoperative recurrence.
结局指标
主要结局
Tumor Evaluation (Recurrence)
时间窗: Follow-up at regular intervals during the first 3 years post-surgery.
Assessment of tumor recurrence through clinical and imaging evaluations.
次要结局
- Overall Survival (OS)(Patients will be monitored for overall survival for up to 5 years post-surgery.)