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

NCT07060287 | Completed

• 1 other identifier: 2019S00479
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Nodule Cm

Keywords

miR-21; miR-486; clock-guided anatomical positioning; pulmonary nodules; survival analysis; VATS

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (3)

• 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

Study Arms (2)

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.

Procedure: Clock-Guided Minimally Invasive Surgery

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.

Procedure: Clock-Guided Minimally Invasive Surgery

Interventions

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.

High miR-21/miR-486 Expression Group (n=62); Low miR-21/miR-486 Expression Group (n=76)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Intraoperatively resected pulmonary nodule tissues were collected, and total RNA was extracted for miRNA quantification.

MeSH Terms

Conditions

Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: January 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

CN (1)