Pulmonary Nodule CmNCT07060287

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

An observational study of Pulmonary Nodule Cm, run by The First Hospital of Hebei Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Nodule Cm
What is being tested?: Clock-Guided Minimally Invasive Surgery
Type of treatment: Surgery or procedure
How many people: 138 participants
Where: 1 siteChina
Study dates: 1 Jan 2020to 1 Jan 2022
How long will I take part?: 24 Months
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

China1 site

The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000

Other trials in China

About this study

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

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.

Read the detailed 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.

Conditions: Pulmonary Nodule Cm
Being tested: Clock-Guided Minimally Invasive Surgery
Keywords: miR-21, miR-486, clock-guided anatomical positioning, pulmonary nodules, survival analysis, VATS
Medical subject headings: Multiple Pulmonary Nodules

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Clock-Guided Minimally Invasive SurgeryProcedure or surgery
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.

Study groups in NCT07060287
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: Clock-Guided Minimally Invasive Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival (OS)
Defined as the time from the date of surgery to the date of death from any cause.
Measured: 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.
Measured: Assessed up to January 2022 (up to 24 months of follow-up)

Secondary outcomes (3)

Residual Nodule Size
Measurement of the maximum diameter (in cm) of any residual or recurrent nodule on chest CT scans.
Measured: 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.
Measured: 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.
Measured: Assessed at 6 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20201 Jan 2022

First posted11 Jul 2025
Study start1 Jan 2020
Primary completion1 Jan 2022
Study completion1 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pulmonary Nodule CmStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 138 participants (actual)
Target duration: 24 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT07060287
Sponsor's protocol ID: 2019S00479
Status last verified: Jul 2025
First submitted: 2 Jul 2025
Last updated: 11 Jul 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Intraoperative Longitude-Latitude-Depth Localization Versus Preoperative CT-Guided Percutaneous Lung Puncture Localization for 0.8-2 cm Peripheral Pulmonary Nodules
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Non-small Cell Lung Cancer, Early-stage Lung Cancer
Not yet recruiting
Sedation of Remazolam Combined With Afentanil in Non-intubated Thoracoscopic Pulmonary Surgery
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All Pulmonary Nodule Cm trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Predictive Value of miR-21 and miR-486 Expression in Patients Undergoing Clock-Guided Minimally Invasive Surgery for Pulmonary Nodules
ClinicalTrials.gov ID: NCT07060287
Acronym / sponsor ID: 2019S00479
Conditions: Pulmonary Nodule Cm
Keywords: miR-21, miR-486, clock-guided anatomical positioning, pulmonary nodules, survival analysis, VATS
Study type: Observational
Recruitment status: Completed
Enrolment: 138 participants (actual)
Lead sponsor: The First Hospital of Hebei Medical UniversityUniversity, hospital or other
Study start: 1 Jan 2020 (actual)
Primary completion: 1 Jan 2022 (actual)
Study completion: 1 Jan 2022 (actual)
First posted: 11 Jul 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 24 Months
Number of arms: 2

Arm	Type	Receives
High miR-21/miR-486 Expression Group (n=62)	–	Procedure: Clock-Guided Minimally Invasive SurgeryPatients 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.
Low miR-21/miR-486 Expression Group (n=76)	–	Procedure: Clock-Guided Minimally Invasive SurgeryPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Clock-Guided Minimally Invasive SurgeryAll 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.	Procedure or surgery	High miR-21/miR-486 Expression Group (n=62), Low miR-21/miR-486 Expression Group (n=76)

Primary outcome

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.
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.

3 secondary outcomes

Residual Nodule Size
Time frame: Assessed at 6 months postoperatively
Residual Nodule Density
Time frame: Assessed at 6 months postoperatively
Residual Nodule Metabolic Activity
Time frame: Assessed at 6 months postoperatively

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.

Related trials for Pulmonary Nodule Cm

Recruiting
Intraoperative Longitude-Latitude-Depth Localization Versus Preoperative CT-Guided Percutaneous Lung Puncture Localization for 0.8-2 cm Peripheral Pulmonary Nodules
Pulmonary Nodule, Solitary, Peripheral Pulmonary Nodules
Not yet recruiting
Segmentectomy Versus Lobectomy for Deep Solid-Dominant Early-Stage NSCLC
Non-Small Cell Lung Cancer, Stage IA Non-Small Cell Lung Cancer
Recruiting
Septum-guided Segmentectomy for Deep Early-stage Lung Cancer (SGS2512)
Non-small Cell Lung Cancer, Early-stage Lung Cancer
Not yet recruiting
Sedation of Remazolam Combined With Afentanil in Non-intubated Thoracoscopic Pulmonary Surgery
Pulmonary Nodule Cm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Nodule Cm, run by The First Hospital of Hebei Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Assessed up to January 2022 (up to 24 months of follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07060287.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.