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

Stage IB Non-Small Cell Lung Carcinoma Clinical Trial

Official title:

Clinicopathological Characteristics and Prognosis Analysis of Stage IB Non-small Cell Lung Cancer：A Retrospective Real World Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05979623
• Other study ID #: B2021-128
• Status: Completed
• Start date: January 2016
• Est. completion date: December 2022

Study information

• Verified date: July 2023
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 971
• Est. completion date: December 2022
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Stage IB Non-Small Cell Lung Carcinoma

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RFS	recurrence-free survival	5 years
Secondary	OS	overall survival	5 years