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

Zhongshan Hospital

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

Study Overview

• Status: Recruiting
• Conditions: Progression
• Intervention / Treatment: Procedure: Lymphadenectomy

• Study Type: Interventional
• Enrollment (Anticipated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiang Wei, Dr; Phone Number: 86-21-64041990 86-21-64041990; Email: jiang.wei1@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • Jiang Wei
    • Contact: Jiang Wei; Email: jiang.wei1@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Selective lymphadenectomy	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
No Intervention: Systematic lymph node dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival (OS)	five year overall survival	5 years

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Director: Jiang Wei, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2028

Study Registration Dates

• First Submitted: October 4, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Actual): October 9, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression
• Other Study ID Numbers: B2020-164R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No