Clinicopathological Characteristics and Prognosis Analysis of Stage IB Non-small Cell Lung Cancer

Completed

• Conditions: Stage IB Non-Small Cell Lung Carcinoma

• Registration Number: NCT05979623
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

The goal of this observation study is to learn about clinicopathological characteristics and prognostic factors of stage IB NSCLC. The main question it aims to answer is wheather there is relationship between newly proposed clinicopathological features and the prognosis of stage IB NSCLC .The postoperative pathological and follow-up information of participants will be used for subsequent analysis.

Detailed Description

A total of 971 NSCLC patients with pathological stage IB resected by surgery (R0) from January 2016 to December 2020 at Zhongshan Hospital of Fudan University were reviewed. The primary endpoint is RFS (recurrence-free survival) and OS (overall survival) is the secondary endpoint. The baseline characteristics of the patients were obtained statistically, and factors affecting the prognosis of patients with stage IB NSCLC were analyzed using survival analysis and Cox proportional hazard models. The characteristics of the patients include pathological type, STAS, GGO, gene mutation, and postoperative adjuvant chemotherapy.

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2020-12
• Study Completion: 2022-12
• Status Verified: 2023-07
• Study First Submitted: 2023-07-29
• Study First Submitted QC: 2023-07-29
• Last Update Submitted: 2023-07-29
• Study First Posted: 2023-08-07
• Last Update Posted: 2023-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 971

Inclusion Criteria

• It was confirmed by histopathology as primary non-small cell lung cancer, and the pathological type was LUSC or LUAD;
• According to the 8th edition of TNM clinical staging standards, it is determined as IB stage
• No treatment was performed for the primary lesion of lung cancer before surgery;
• No history of other malignant tumors before surgery;
• Detailed clinical and pathological information, complete survival data, and no missing follow-up data.

Exclusion Criteria

• The postoperative histopathological types include non-scale and non adenocarcinoma, such as lung adenosquamous cell carcinoma, large cell lung cancer, or lung sarcomatoid carcinoma;
• Multiple lesion staging surgery;
• History of merging with other malignant tumors
• Having preoperative treatment;
• Missing follow-up information.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RFS	5 years	recurrence-free survival

Secondary Outcome Measures

Name	Time	Method
OS	5 years	overall survival

Trial Locations

Locations (1)

180 Fenglin Road; 🇨🇳 Shanghai, China