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NCT Number: NCT05979623

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

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.

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Key information

Conditions

Stage IB Non-Small Cell Lung Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

180 Fenglin Road

Shanghai, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. RFS

    Time frame: 5 years

    recurrence-free survival

Secondary outcomes

  1. OS

    Time frame: 5 years

    overall survival

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
Aug 7, 2023
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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