Predictive Value of miR-21 and miR-486 Expression in Patients Undergoing Clock-Guided Minimally Invasive Surgery for Pulmonary Nodules
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This study prospectively evaluated the prognostic value of microRNA-21 (miR-21) and microRNA-486 (miR-486) expression in patients with pulmonary nodules who underwent clock-guided minimally invasive surgery. The study aimed to determine if high expression levels of these miRNAs in resected nodule tissue correlate with poorer clinical outcomes, including larger residual tumor size, higher metabolic activity, and shorter overall and progression-free survival.
详细描述
Pulmonary nodules pose a significant diagnostic and therapeutic challenge. Clock-guided anatomical positioning is a novel technique that improves the precision of minimally invasive surgical resection. MicroRNAs, such as miR-21 and miR-486, are known to be involved in tumorigenesis and have been identified as potential biomarkers. This study was a prospective cohort study designed to investigate the prognostic significance of miR-21 and miR-486 expression in the context of this advanced surgical technique. A total of 138 patients undergoing clock-guided minimally invasive surgery for pulmonary nodules were enrolled. Intraoperative nodule tissues were collected to quantify miRNA expression levels via real-time PCR. Patients were then stratified into high-expression and low-expression groups based on predetermined cut-off values. Postoperative outcomes, including residual nodule characteristics (size, density, metabolic activity) and survival data (Overall Survival and Progression-Free Survival), were collected and compared between the two groups to assess the predictive power of these miRNAs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥18 years;
- •Single or multiple pulmonary nodules confirmed by imaging;
- •Pathologically confirmed or highly suspected malignancy;
- •Eligible for clock-guided minimally invasive surgery;
- •No contraindications to surgery;
- •Signed informed consent.
排除标准
- •Uncontrolled comorbidities (e.g., hypertension >180/110 mmHg, HbA1c >9%);
- •Inoperable status;
- •Benign nodules confirmed by pathology;
- •Severe organ dysfunction (e.g., LVEF <40%, eGFR <30 mL/min);
- •Immunosuppressive therapy;
- •Recent anticancer treatment (<3 months);
- •Lost to follow-up.
结局指标
主要结局
Overall Survival (OS)
时间窗: Assessed up to January 2022 (up to 24 months of follow-up)
Defined as the time from the date of surgery to the date of death from any cause.
Progression-Free Survival (PFS)
时间窗: Assessed up to January 2022 (up to 24 months of follow-up)
Defined as the time from the date of surgery to the date of disease progression (local recurrence or distant metastasis) or death from any cause, whichever occurred first.
次要结局
- Residual Nodule Size(Assessed at 6 months postoperatively)
- Residual Nodule Density(Assessed at 6 months postoperatively)
- Residual Nodule Metabolic Activity(Assessed at 6 months postoperatively)
研究者
Yingchun Ren
Principal investigator
The First Hospital of Hebei Medical University