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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05184829
Other study ID # B2021
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date December 31, 2029

Study information

Verified date December 2021
Source Shanghai Zhongshan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date December 31, 2029
Est. primary completion date December 31, 2028
Accepts healthy volunteers No
Gender All
Age group 25 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
selective lymph node dissection
selective lymph node dissection
Systemic Lymph Node Dissection
Systemic Lymph Node Dissection

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival From enrollment to 36 months after surgery
Secondary Complications The degrees of cough 1-2 Weeks after enrollment (after Surgery)
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