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

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05979623
Collaborator
(none)
971
Enrollment
1
Location
83
Actual Duration (Months)
11.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    971 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Clinicopathological Characteristics and Prognosis Analysis of Stage IB Non-small Cell Lung Cancer：A Retrospective Real World Study
    Actual Study Start Date :
    Jan 1, 2016
    Actual Primary Completion Date :
    Dec 1, 2020
    Actual Study Completion Date :
    Dec 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. RFS [5 years]

      recurrence-free survival

    Secondary Outcome Measures

    1. OS [5 years]

      overall survival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 180 Fenglin Road Shanghai China 200032

    Sponsors and Collaborators

    • Shanghai Zhongshan Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai Zhongshan Hospital
    ClinicalTrials.gov Identifier:
    NCT05979623
    Other Study ID Numbers:
    • B2021-128
    First Posted:
    Aug 7, 2023
    Last Update Posted:
    Aug 7, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Aug 7, 2023