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

Recruiting

• Conditions: Lung Cancer
• Interventions: Other: Sublobar resection; Other: Lobectomy

• Registration Number: NCT06483698
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

Study Timeline

• Study Start: 2024-03-01
• Study First Submitted: 2024-03-12
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-29
• Last Update Submitted: 2024-06-29
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-03
• Primary Completion: 2026-03
• Study Completion: 2034-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sublobar resection group	Sublobar resection	Patients in this group have received Sublobar resection.
Lobectomy group	Lobectomy	Patients in this group have received lobectomy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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) Rate	From 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 Relapse	Within 10 years after surgery	Relapse was defined as disease recurrence at any site.
Perioperative Complication rate	Within 6 months after surgery	Complications after the surgery

Trial Locations

Locations (1)

Shugeng Gao; 🇨🇳 Beijing, Beijing, China