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

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

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.

Study Overview

• Status: Completed
• Conditions: Stage IB Non-Small Cell Lung Carcinoma

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 Type: Observational
• Enrollment (Actual): 971

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200032
    • 180 Fenglin Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

NSCLC patients with pathological stage IB resected by surgery (R0)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ZS-IB-NSCLC; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RFS	recurrence-free survival	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	overall survival	5 years

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Chair: Di Ge, Ph.D;M.D, Zhongshan Hospital, Fudan University, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: July 29, 2023
• First Submitted That Met QC Criteria: July 29, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: July 29, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: B2021-128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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