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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High miR-21/miR-486 Expression Group (n=62) | 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. |
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| Low miR-21/miR-486 Expression Group (n=76) | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clock-Guided Minimally Invasive Surgery | Procedure | All participants underwent video-assisted thoracoscopic surgery (VATS) for pulmonary nodule resection. Nodule localization was performed using a clock-guided anatomical positioning technique with a 3D reconstruction system. The surgical procedure included wedge resection, segmentectomy, or lobectomy based on clinical judgment. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Defined as the time from the date of surgery to the date of death from any cause. | Assessed up to January 2022 (up to 24 months of follow-up) |
| Progression-Free Survival (PFS) | 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. | Assessed up to January 2022 (up to 24 months of follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Residual Nodule Size | Measurement of the maximum diameter (in cm) of any residual or recurrent nodule on chest CT scans. | Assessed at 6 months postoperatively |
| Residual Nodule Density | Measurement of the density of any residual or recurrent nodule in Hounsfield Units (HU) on non-contrast chest CT scans. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population comprised 138 adult patients (age ≥18 years) with pulmonary nodules who were scheduled for clock-guided minimally invasive surgery at the Department of Thoracic Surgery, the First Hospital of Hebei Medical University. Participants were prospectively and consecutively enrolled if they had pathologically confirmed or highly suspected malignant nodules and met all predefined inclusion and exclusion criteria. All participants provided written informed consent prior to enrollment in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
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| ID | Term |
|---|---|
| D055613 | Multiple Pulmonary Nodules |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
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Intraoperatively resected pulmonary nodule tissues were collected, and total RNA was extracted for miRNA quantification.
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| Assessed at 6 months postoperatively |
| Residual Nodule Metabolic Activity | Quantification of metabolic activity of any residual or recurrent nodule using the maximum standardized uptake value (SUVmax) on 18F-FDG PET/CT scans. | Assessed at 6 months postoperatively |
| D009369 |
| Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |