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Clinical Trials/NCT06483698
NCT06483698
Recruiting
Not Applicable

Real-world Clinical Outcomes of Patients With Early-stage Lung Cancer After the Surgery: A Retrospective Multi-center Study (EarlyLC-RW)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 site in 1 country20,000 target enrollmentMarch 1, 2024
ConditionsLung Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Enrollment
20000
Locations
1
Primary Endpoint
Disease-free survival(DFS)
Status
Recruiting
Last Updated
8 months ago

Overview

Brief Summary

The goal of this observational study is to evaluate the efficacy and long-term clinical outcomes of early-stage lung cancer patients who have received surgery using the real-world data. The main questions it aims to answer are:

  • What is the best surgical strategy for patients with early-stage lung cancer?
  • What are the risk factors for early-stage lung cancer? Participants will receive surgery and the study will analyze the real-world data.

Detailed Description

This observational study aims to comprehensively evaluate the effectiveness and long-term clinical outcomes of surgical interventions in early-stage lung cancer patients, utilizing real-world data. Central to this investigation are two key questions: * What is the optimal surgical approach for managing early-stage lung cancer? * What are the primary risk factors associated with the development of early-stage lung cancer? Participants will undergo surgical procedures, and through rigorous analysis of real-world data, this study endeavors to provide nuanced insights into these fundamental queries, fostering advancements in clinical decision-making and patient management strategies.

Registry
clinicaltrials.gov
Start Date
March 1, 2024
End Date
December 1, 2034
Last Updated
8 months ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Aged between 18 and 85;
  • Did not receive neoadjuvant therapy before surgery;
  • No history of radiation therapy;
  • Eastern Cooperative Oncology Group (ECOG) score is 0-1;
  • Have complete clinically relevant information including imaging data;
  • All patients underwent relevant preoperative examinations;
  • Stage I lung cancer (International Association for the Study of Lung Cancer/The Union for International Cancer Control staging eighth edition);

Exclusion Criteria

  • Have previously received chemotherapy, radiotherapy and other anti-tumor therapy;
  • Data loss and error in medical records due to human/objective reasons.

Outcomes

Primary Outcomes

Disease-free survival(DFS)

Time Frame: Defined as the time from the date of surgery until the date of first documented progression or death (by any cause in the absence of recurrence), whichever came first, assessed up to 10 years.

Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence).

Secondary Outcomes

  • Overall Survival (OS)(From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 10 years.)
  • 5-year Overall Survival (overall survival) Rate(From date of surgery until date of death due to any cause. Assessed at 5 years.)
  • Patterns of Relapse(Within 10 years after surgery)
  • Perioperative Complication rate(Within 6 months after surgery)

Study Sites (1)

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