Prognostic Value of miR-21 and miR-486 in Pulmonary Nodule Surgery

Hebei Medical University

Status: Completed

Conditions: Pulmonary Nodule Cm

Treatments: Procedure: Clock-Guided Minimally Invasive Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT07060287

2019S00479

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

138 participants in 2 patient groups

High miR-21/miR-486 Expression Group (n=62)

Description:

Patients whose resected pulmonary nodule tissue showed expression of miR-21 greater than a 2.5-fold change or miR-486 greater than a 1.8-fold change compared to reference levels, as determined by ROC curve analysis.

Treatment:

Procedure: Clock-Guided Minimally Invasive Surgery

Low miR-21/miR-486 Expression Group (n=76)

Description:

Patients whose resected pulmonary nodule tissue showed expression of miR-21 less than or equal to a 2.5-fold change and miR-486 less than or equal to a 1.8-fold change compared to reference levels.

Treatment:

Procedure: Clock-Guided Minimally Invasive Surgery