Comparing two surgical approaches for early-stage lung cancer with ground-glass nodules
Official title: Mediastinal Lymph Node Dissection Versus Spared Mediastinal Lymph Node Dissection in Stage IA Non-small Cell Lung Cancer Presented as Ground-glass Nodules: Study Protocol of a Phase III, Randomized, Multi-center Trial (MELDSIG) in China
Run by Tianjin Medical University Cancer Institute and Hospital · NCT04631770 · Data updated 2026-11-12
This study is testing which of two surgical methods is better for people with early-stage lung cancer that has ground-glass nodules, to see which one helps them live longer and stay cancer-free.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 1362 (estimated) |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Status | Recruiting |
| Started | May 1, 2022 |
| Main results expected | May 1, 2024 |
| Study ends | May 1, 2029 |
| Registry record updated | September 28, 2023 |
| Trial ID | NCT04631770 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients diagnosed with clinical stage IA non-small cell lung cancer who have a single ground-glass nodule and no lymph node metastasis.
✕Probably not a fit
Patients with a history of other malignancies, active infections, or severe pulmonary conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of mediastinal lymph node dissection versus spared mediastinal lymph node dissection in patients with stage I non-small cell lung cancer (NSCLC) characterized by ground-glass nodules. It is a prospective, multicenter, randomized trial involving 1,362 patients, with an enrollment period of three years followed by a five-year observation period. The study aims to compare overall survival and disease-free survival rates between the two surgical approaches, focusing on the unique characteristics of ground-glass nodules that may influence treatment outcomes.
Why it matters
Potential benefit: If successful, this study could lead to more tailored surgical approaches for patients with early-stage lung cancer, potentially improving survival rates and reducing unnecessary procedures.
How similar studies have gone: While there have been studies on surgical approaches for lung cancer, this specific comparison of mediastinal lymph node dissection techniques in the context of ground-glass nodules is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Thin-slice HRCT shows single GGN with C/T ≤ 0.5 and no lymph node metastasis; * Clinical stage IA NSCLC (TNM 8th classification) diagnosed prior or in surgery; * No history of malignancies within past 5 years or lung surgery; * No anti-cancer treatment prior to surgery. Exclusion Criteria: * Simultaneous or metachronous (within the past 5 years) double cancers; * Active bacterial or fungous infection; * Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema; * Systemic steroidal medication; * Uncontrollable diabetes mellitus; (vi) Uncontrollable hypertension or history of severe heart disease, heart failure.
Where it's running
-
Ethics review board of Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China Recruiting
Study contacts
- Principal investigator: Zhenfa Zhenfa, MD — Tianjin Medical University Cancer Institute and Hospital
- Study coordinator: Zhenfa Zhang, MD
- Email: zhangzhenfa1973@163.com
- Phone: +862223340123
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
AI-assisted longitudinal CT to guide indeterminate lung nodules
This trial tests whether giving doctors an AI report that tracks nodules over serial CT scans helps reduce unnecessary benign lung resections in patients with indeterminate nodules.
-
MRD-guided postoperative monitoring and adaptive treatment for resectable NSCLC
This study tests a personalized follow-up and treatment plan using ctDNA MRD testing and pathology to guide adjuvant therapy after surgery for stage IB-IIIA NSCLC treated with neoadjuvant immunotherapy.
-
Telerehabilitation exercise program after lung cancer surgery
A remote rehabilitation program with guided exercises is tested to help adults after lung cancer surgery recover better.
-
Impact of Exercise on Tumor Immunity in NSCLC Patients Receiving Neoadjuvant Chemo-Immunotherapy
A structured exercise program is being tested to see if it boosts immune cells in the tumor for patients with resectable NSCLC undergoing pre-surgery chemo-immunotherapy.
-
Low-Dose CT Lung Cancer Screening in Kuwait: Feasibility and Uptake
This pilot tests whether offering low-dose CT lung cancer screening to high-risk adults in Kuwait is workable and acceptable, with about 500 participants completing a baseline scan.
-
Nitride-based Raman biochip for lung cancer diagnosis and monitoring
A large observational study in Taiwan will test whether a blood-based nitride-based Raman biochip can help diagnose lung cancer and monitor patients over time.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.