Back to resultsA 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
Primary Purpose
Progression
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lymphadenectomy
Sponsored by
About this trial
This is an interventional other trial for Progression
Eligibility Criteria
Inclusion Criteria:
- Aged between 18 and 75 years;
- GGO is diagnosed by lung CT and failure to subside after 3 months (the patient having been re-examined by thin-section CT);
- The maximum diameter of the GGO is smaller than 3cm;
- The maximum diameter of the solid component in the GGO is more than 50%;
- The patient is able to undergo the lobectomy
- 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:
- Patients with a history of using immunosuppressive or hormonal drugs;
- Patients receiving radiotherapy or chemotherapy;
- Patients who fail to comply with our follow-up strategy;
- Other situations that are not in conformity with the standards and requirements of this trial.
Sites / Locations
- Jiang WeiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Selective lymphadenectomy
Systematic lymph node dissection
Arm Description
Outcomes
Primary Outcome Measures
overall survival (OS)
five year overall survival
Secondary Outcome Measures
Full Information
NCT ID
NCT04581122
First Posted
October 4, 2020
Last Updated
October 8, 2020
Sponsor
Shanghai Zhongshan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04581122
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
Official Title
Zhongshan Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progression
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Selective lymphadenectomy
Arm Type
Experimental
Arm Title
Systematic lymph node dissection
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Lymphadenectomy
Intervention Description
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
Primary Outcome Measure Information:
Title
overall survival (OS)
Description
five year overall survival
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged between 18 and 75 years;
GGO is diagnosed by lung CT and failure to subside after 3 months (the patient having been re-examined by thin-section CT);
The maximum diameter of the GGO is smaller than 3cm;
The maximum diameter of the solid component in the GGO is more than 50%;
The patient is able to undergo the lobectomy
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:
Patients with a history of using immunosuppressive or hormonal drugs;
Patients receiving radiotherapy or chemotherapy;
Patients who fail to comply with our follow-up strategy;
Other situations that are not in conformity with the standards and requirements of this trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang Wei, Dr
Phone
86-21-64041990
Ext
86-21-64041990
Email
jiang.wei1@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiang Wei
Organizational Affiliation
Fudan University
Official's Role
Study Director
Facility Information:
Facility Name
Jiang Wei
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiang Wei
Email
jiang.wei1@zs-hospital.sh.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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
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