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Real-world Clinical Outcomes of Patients With Early-stage Lung Cancer After the Surgery

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06483698
Acronym
EarlyLC-RW
Enrollment
20000
Registered
2024-07-03
Start date
2024-03-01
Completion date
2034-12-31
Last updated
2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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.

Interventions

Sublobar resection is a series of surgical approaches for lung cancer.

OTHERLobectomy

Lobectomy is the surgical approach for lung cancer.

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years

Inclusion criteria

1. Aged between 18 and 85; 2. Did not receive neoadjuvant therapy before surgery; 3. No history of radiation therapy; 4. Eastern Cooperative Oncology Group (ECOG) score is 0-1; 5. Have complete clinically relevant information including imaging data; 6. All patients underwent relevant preoperative examinations; 7. Stage I lung cancer (International Association for the Study of Lung Cancer/The Union for International Cancer Control staging eighth edition);

Exclusion criteria

1. Have previously received chemotherapy, radiotherapy and other anti-tumor therapy; 2. Data loss and error in medical records due to human/objective reasons.

Design outcomes

Primary

MeasureTime frameDescription
Disease-free survival(DFS)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

MeasureTime frameDescription
Overall Survival (OS)From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 10 years.OS is defined as the time from surgery time until death from any cause.
5-year Overall Survival (overall survival) RateFrom date of surgery until date of death due to any cause. Assessed at 5 years.The time from surgery time until death from any cause, estimated from a Kaplan Meier plot of OS at the time of the primary analysis.
Patterns of RelapseWithin 10 years after surgeryRelapse was defined as disease recurrence at any site.
Perioperative Complication rateWithin 6 months after surgeryComplications after the surgery

Countries

China

Contacts

Primary ContactShugeng Gao, MD
gaoshugeng@cicams.ac.cn8610-87788177

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026