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NCT Number: NCT06483698

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

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shugeng Gao

Beijing, Beijing Municipality, 100020, China

Location status: Recruiting

Location contact

Shugeng Gao, MD

CONTACT

[email protected]

010-87788177

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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);

Exclusion criteria

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

Treatment and study plan

Sublobar resection

Other

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

Lobectomy

Other

Lobectomy is the surgical approach for lung cancer.

Primary outcomes

  1. Disease-free survival(DFS)

    Time frame: 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 outcomes

  1. Overall Survival (OS)

    Time frame: 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.

  2. 5-year Overall Survival (overall survival) Rate

    Time frame: 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.

  3. Patterns of Relapse

    Time frame: Within 10 years after surgery

    Relapse was defined as disease recurrence at any site.

  4. Perioperative Complication rate

    Time frame: Within 6 months after surgery

    Complications after the surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Shugeng Gao, MD

CONTACT

[email protected]

8610-87788177

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Acronym: EarlyLC-RW

Important dates

Study start
2024
Primary completion
2026
Study completion
2034
First posted
Jul 3, 2024
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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