Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04631770
Status:
RECRUITING
Last Update Posted:
2023-09-28
First Post:
2020-11-15
Brief Title:
Mediastinal Lymph Node Dissection Versus Spared Mediastinal Lymph Node Dissection in Stage I GGN NSCLC
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
The study is a non-inferior statistical comparison with 681 patients in each group The anticipated enroll period is 3 years followed by observation period of 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None