Actively Recruiting
A Multiple-center Study on the Effect of Different Ways of Lymph Node Dissection on the Prognosis of Ground Glass Nodules Smaller Than 3cm with More Than 50% Solid Components
Led by Shanghai Zhongshan Hospital · Updated on 2020-10-09
1500
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of different methods of lymph node removal on the prognosis of small ground glass nodules in the lungs. The nodules involved are less than 3 cm in size and have more than 50% solid components. This study is conducted across multiple centers to better understand the best approach for these cases and is sponsored by Shanghai Zhongshan Hospital. Participants with ground glass nodules that meet the size and composition criteria will be randomly assigned to one of two groups: selective lymphadenectomy or systematic lymph node dissection. Both are surgical procedures aimed at removing lymph nodes, but they differ in how extensive the removal is. The study will monitor participants for five years to assess overall survival. During the study, participants will be evaluated through lung CT scans and other clinical assessments to monitor their progress and response to the lymph node removal methods. Researchers will track overall survival over a five-year period to determine which surgical approach may offer better outcomes. Participants will be followed regularly to ensure adherence to the study and track any changes in their condition throughout the study duration, which started in 2020 and is expected to complete by the end of 2028.
CONDITIONS
Brief Title
A Multiple-center Study on the Effect of Different Ways of Lymph Node Dissection on the Prognosis of Ground Glass Nodules Smaller Than 3cm and With More Than 50% Solid Components
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years
- Ground glass nodule (GGO) diagnosed by lung CT that does not subside after 3 months
- Maximum diameter of the GGO is smaller than 3cm
- Maximum diameter of the solid component in the GGO is more than 50%
- Able to undergo lobectomy surgery
- Able to understand and comply with the study and has provided written informed consent
You will not qualify if you...
- History of using immunosuppressive or hormonal drugs
- Receiving radiotherapy or chemotherapy
- Failure to comply with follow-up strategy
- Other conditions not meeting the standards and requirements of this trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to hospital discharge
Participants undergo lobectomy surgery with either selective lymphadenectomy or systematic lymph node dissection as part of the trial.
1 surgery visit and several immediate post-operative assessments
Duration - Up to 5 years
Participants are followed to monitor recovery and longer-term outcomes after surgery including overall survival.
Periodic visits for follow-up assessments
Trial Site Locations
Total: 1 location
1
Jiang Wei
Shanghai, China, 200032
Actively Recruiting
Research Team
J
Jiang Wei, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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