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Completed

NCT Number: NCT07060287

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Overall Survival (OS)

    Time frame: 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.

  2. Progression-Free Survival (PFS)

    Time frame: 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.

Secondary outcomes

  1. Residual Nodule Size

    Time frame: Assessed at 6 months postoperatively

    Measurement of the maximum diameter (in cm) of any residual or recurrent nodule on chest CT scans.

  2. Residual Nodule Density

    Time frame: Assessed at 6 months postoperatively

    Measurement of the density of any residual or recurrent nodule in Hounsfield Units (HU) on non-contrast chest CT scans.

  3. Residual Nodule Metabolic Activity

    Time frame: Assessed at 6 months postoperatively

    Quantification of metabolic activity of any residual or recurrent nodule using the maximum standardized uptake value (SUVmax) on 18F-FDG PET/CT scans.

Sponsors and collaborators

Lead sponsor

The First Hospital of Hebei Medical University

Other

Registry information

Official study title

Predictive Value of miR-21 and miR-486 Expression in Patients Undergoing Clock-Guided Minimally Invasive Surgery for Pulmonary Nodules

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 11, 2025
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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