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

NCT06483698 | Recruiting

• 1 other identifier: 23/516-4259
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall Survival (OS)

  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

  From date of surgery until date of death due to any cause. Assessed at 5 years.

• Patterns of Relapse

  Within 10 years after surgery

• Perioperative Complication rate

  Within 6 months after surgery

Study Arms (2)

Sublobar resection group

Patients in this group have received Sublobar resection.

Other: Sublobar resection

Lobectomy group

Patients in this group have received lobectomy.

Other: Lobectomy

Interventions

Sublobar resection OTHER

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

Sublobar resection group

Lobectomy OTHER

Lobectomy is the surgical approach for lung cancer.

Lobectomy group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lung cancer who have received surgery.

You may qualify if:

• 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);

You may not qualify if:

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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Shugeng Gao

Beijing, Beijing Municipality, 100020, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Anterior Temporal Lobectomy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Shugeng Gao, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shugeng Gao, MD

CONTACT

8610-87788177; gaoshugeng@cicams.ac.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: July 3, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2034
• Last Updated: August 29, 2025

Record last verified: 2025-04

Locations

CN (1)