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A Single-center Study on the Effect of Systemic/Selective Lymph Node Dissection on the Prognosis of Ground Glass Nodules Smaller Than 3cm and With Components With Consolidation/Tumor Ratio Between 0.5-1

Primary Purpose

Progression, Postoperative Recovery

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
selective lymph node dissection
Systemic Lymph Node Dissection
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Progression

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients enrolled in the study must meet all of the following conditions:

  • 1.Aged between 25 and 75 years;
  • 2. GGO is diagnosed by thin-section lung CT (thickness <1.5mm) within one month before surgery;
  • 3. The maximum diameter of the GGO is smaller than 3cm;
  • 4. The solid component in GGO between 50%-100%;
  • 5. Preoperative examination showed that the patient could tolerate 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 lung surgery;
  • 2. Postoperative pathology showed non-primary lung cancer;
  • 3. The scope of surgical resection is larger than one lung lobe;
  • 4. Patients with a history of other tumors;
  • 5. Patients with severe complications (coronary heart disease, valvular heart disease, end-stage renal disease, severe liver cirrhosis);
  • 6. Unable to cooperate with the researchers because of dementia or cognitive decline
  • 7. Other situations that are not in conformity with the standards and requirements of this trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    systemic lymph node dissection group

    selective lymph node dissection

    Arm Description

    systemic lymph node dissection group

    selective lymph node dissection

    Outcomes

    Primary Outcome Measures

    Overall survival

    Secondary Outcome Measures

    Complications
    The degrees of cough

    Full Information

    First Posted
    December 15, 2021
    Last Updated
    December 28, 2021
    Sponsor
    Shanghai Zhongshan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05184829
    Brief Title
    A Single-center Study on the Effect of Systemic/Selective Lymph Node Dissection on the Prognosis of Ground Glass Nodules Smaller Than 3cm and With Components With Consolidation/Tumor Ratio Between 0.5-1
    Official Title
    A Single-center Study on the Effect of Systemic/Selective Lymph Node Dissection on the Prognosis of Ground Glass Nodules Smaller Than 3cm and With Components With Consolidation/Tumor Ratio Between 0.5-1
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2028 (Anticipated)
    Study Completion Date
    December 31, 2029 (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
    Yes

    5. Study Description

    Brief Summary
    A single-center study on the effect of systemic/selective lymph node dissection on the prognosis of ground glass nodules smaller than 3cm and with components with consolidation/tumor ratio between 0.5-1
    Detailed Description
    A single-center study on the effect of systemic/selective lymph node dissection on the prognosis of ground glass nodules smaller than 3cm and with components with consolidation/tumor ratio between 0.5-1

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Progression, Postoperative Recovery

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    systemic or selective lymph node dissection group
    Masking
    None (Open Label)
    Masking Description
    open label
    Allocation
    Randomized
    Enrollment
    500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    systemic lymph node dissection group
    Arm Type
    Active Comparator
    Arm Description
    systemic lymph node dissection group
    Arm Title
    selective lymph node dissection
    Arm Type
    Experimental
    Arm Description
    selective lymph node dissection
    Intervention Type
    Other
    Intervention Name(s)
    selective lymph node dissection
    Intervention Description
    selective lymph node dissection
    Intervention Type
    Other
    Intervention Name(s)
    Systemic Lymph Node Dissection
    Intervention Description
    Systemic Lymph Node Dissection
    Primary Outcome Measure Information:
    Title
    Overall survival
    Time Frame
    From enrollment to 36 months after surgery
    Secondary Outcome Measure Information:
    Title
    Complications
    Description
    The degrees of cough
    Time Frame
    1-2 Weeks after enrollment (after Surgery)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients enrolled in the study must meet all of the following conditions: 1.Aged between 25 and 75 years; 2. GGO is diagnosed by thin-section lung CT (thickness <1.5mm) within one month before surgery; 3. The maximum diameter of the GGO is smaller than 3cm; 4. The solid component in GGO between 50%-100%; 5. Preoperative examination showed that the patient could tolerate 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 lung surgery; 2. Postoperative pathology showed non-primary lung cancer; 3. The scope of surgical resection is larger than one lung lobe; 4. Patients with a history of other tumors; 5. Patients with severe complications (coronary heart disease, valvular heart disease, end-stage renal disease, severe liver cirrhosis); 6. Unable to cooperate with the researchers because of dementia or cognitive decline 7. Other situations that are not in conformity with the standards and requirements of this trial.

    12. IPD Sharing Statement

    Learn more about this trial

    A Single-center Study on the Effect of Systemic/Selective Lymph Node Dissection on the Prognosis of Ground Glass Nodules Smaller Than 3cm and With Components With Consolidation/Tumor Ratio Between 0.5-1

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