Clinical trial NCT06483698: Real-world Clinical Outcomes of Patients With Early-stage Lung Cancer After the Surgery
Official title: Real-world Clinical Outcomes of Patients With Early-stage Lung Cancer After the Surgery: A Retrospective Multi-center Study (EarlyLC-RW)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lung cancer who have received surgery.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease-free survival(DFS)
timeFrame: 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 outcomes:
measure: Overall Survival (OS)
timeFrame: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 10 years.
measure: 5-year Overall Survival (overall survival) Rate
timeFrame: From date of surgery until date of death due to any cause. Assessed at 5 years.
measure: Patterns of Relapse
timeFrame: Within 10 years after surgery
measure: Perioperative Complication rate
timeFrame: Within 6 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Shugeng Gao
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Shugeng Gao, MD
role: PRINCIPAL_INVESTIGATOR
References: