Real-world Clinical Outcomes of Patients With Early-stage Lung Cancer After the Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sublobar resection, Lobectomy.
- Who it may be relevant to
- Registry conditions: Lung Cancer. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Real-world Clinical Outcomes of Patients With Early-stage Lung Cancer After the Surgery: A Retrospective Multi-center Study (EarlyLC-RW)
Overview
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.
Interventions
- Other Sublobar resection
Sublobar resection is a series of surgical approaches for lung cancer. - Other Lobectomy
Lobectomy is the surgical approach for lung cancer.
Primary outcome measures
- 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.]
Secondary outcome measures (4)
- Overall Survival (OS) [Time frame: 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 [Time frame: From date of surgery until date of death due to any cause. Assessed at 5 years.]
- Patterns of Relapse [Time frame: Within 10 years after surgery]
- Perioperative Complication rate [Time frame: Within 6 months after surgery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Shugeng Gao — Beijing
Identifiers
NCT: NCT06483698 · 23/516-4259