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

Progression Clinical Trial

Official title:

Zhongshan Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04581122
• Other study ID #: B2020-164R
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 31, 2028

Study information

• Verified date: October 2020
• Source: Shanghai Zhongshan Hospital
• Contact: Jiang Wei, Dr
• Phone: 86-21-64041990
• Email: jiang.wei1[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multiple-center study on the effect of different ways of lymph node dissection on the prognosis of less than 3cm ground glass nodules with more than solid components

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Aged between 18 and 75 years;

2. GGO is diagnosed by lung CT and failure to subside after 3 months (the patient having been re-examined by thin-section CT);

3. The maximum diameter of the GGO is smaller than 3cm;

4. The maximum diameter of the solid component in the GGO is more than 50%;

5. The patient is able to undergo the lobectomy

6. The patient is able to understand and comply with the study and has provided written informed consent.

Exclusion Criteria:

-

Patients meeting any of the following criteria are not eligible for this trial:

1. Patients with a history of using immunosuppressive or hormonal drugs;

2. Patients receiving radiotherapy or chemotherapy;

3. Patients who fail to comply with our follow-up strategy;

4. Other situations that are not in conformity with the standards and requirements of this trial.

Related Conditions & MeSH terms

• Disease Progression
• Progression

Intervention

Procedure:
• Lymphadenectomy
Patients with ground glass nodules smaller than 3cm and with more than 50%solid components would randomly assigned to selective lymphadenectomy group or systematic lymph node dissection group

Locations

Country	Name	City	State
China	Jiang Wei	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival (OS)	five year overall survival	5 years