NCT04631770Recruiting
Mediastinal Lymph Node Dissection Versus Spared Mediastinal Lymph Node Dissection in Stage I GGN NSCLC
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
Source: ClinicalTrials.gov · Last updated 28 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Lung cancer is the leading cause of cancer related death worldwide. Lobectomy or sub-lobectomy with mediastinal lymph node dissection is the standard surgery. About 50% lung nodules are pure ground-glass or part-solid nodules. Non-solid nodules rarely develop mediastinal lymph node metastasis. The present study is a prospective, multicenter and randomized clinical trial, comparing the overall survival and disease-free survival of whether performing mediastinal lymph node dissection in non-small cell lung cancer with ground-glass nodule CT features.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1362 (estimated)
- First submitted
- 15 Nov 2020
- Start date
- 1 May 2022
- Primary completion date
- 1 May 2024
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Lung cancer, Childhood cancers
- NCT number
- NCT04631770
What you commit to
- Study type: Interventional
- Planned participants: 1362
- From 1 May 2022 to the primary completion date, 1 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Systemic steroidal medication;
Other illness
- Simultaneous or metachronous (within the past 5 years) double cancers;
- Active bacterial or fungous infection;
- Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema;
- Uncontrollable diabetes mellitus; (vi) Uncontrollable hypertension or history of severe heart disease, heart failure.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ethics review board of Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.