Real-world Clinical Outcomes of Patients With Early-stage Lung Cancer After the Surgery (EarlyLC-RW)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Sublobar resection; Other: Lobectomy

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 Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: Shugeng Gao, MD; Phone Number: 8610-87788177; Email: gaoshugeng@cicams.ac.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100020
      • Recruiting
      • Shugeng Gao
      • Contact: Shugeng Gao, MD; Phone Number: 010-87788177; Email: gaoshugeng@cicams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with lung cancer who have received surgery.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sublobar resection group; Patients in this group have received Sublobar resection.	Other: Sublobar resection; Sublobar resection is a series of surgical approaches for lung cancer.
Lobectomy group; Patients in this group have received lobectomy.	Other: Lobectomy; Lobectomy is the surgical approach for lung cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival(DFS)	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).	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

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from surgery time until death from any cause.	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	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.	From date of surgery until date of death due to any cause. Assessed at 5 years.
Patterns of Relapse	Relapse was defined as disease recurrence at any site.	Within 10 years after surgery
Perioperative Complication rate	Complications after the surgery	Within 6 months after surgery

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Shugeng Gao, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): December 1, 2034

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: June 29, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Surgical Procedures, Operative; Neurosurgical Procedures; Anterior Temporal Lobectomy
• Other Study ID Numbers: 23/516-4259

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No