Lung CancerEarlyLC-RWNCT06483698
Real-world Clinical Outcomes of Patients With Early-stage Lung Cancer After the Surgery
An observational study of Lung Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Sublobar resection and Lobectomy
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to Dec 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
Study population: Patients with lung cancer who have received surgery.
Who may be able to join
- 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);
Who cannot join
- Have previously received chemotherapy, radiotherapy and other anti-tumor therapy;
- Data loss and error in medical records due to human/objective reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shugeng Gao
Beijing, Beijing Municipality, 100020
Shugeng Gao, MD, 010-87788177, gaoshugeng@cicams.ac.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Sublobar resection, Lobectomy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublobar resectionOther
Sublobar resection is a series of surgical approaches for lung cancer.
LobectomyOther
Lobectomy is the surgical approach for lung cancer.
| Study group | Role | What they receive |
|---|---|---|
| Sublobar resection group | Patients in this group have received Sublobar resection. Receives: Other: Sublobar resection | |
| Lobectomy group | Patients in this group have received lobectomy. Receives: Other: Lobectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
OS is defined as the time from surgery time until death from any cause.
Measured: 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.
Measured: 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.
Measured: Within 10 years after surgery
Perioperative Complication rate
Complications after the surgery
Measured: Within 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Mar 2024
- Primary completionMar 2026 (estimated)
- Study completionDec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shugeng Gao, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483698
- Sponsor's protocol ID
- 23/516-4259
- Acronym
- EarlyLC-RW
- Status last verified
- Apr 2025
- First submitted
- 12 Mar 2024
- Last updated
- 29 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Clinical Outcomes of Patients With Early-stage Lung Cancer After the Surgery: A Retrospective Multi-center Study (EarlyLC-RW)
- ClinicalTrials.gov ID
- NCT06483698
- Acronym / sponsor ID
- EarlyLC-RW / 23/516-4259
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Dec 2034 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sublobar resection group | – | Other: Sublobar resectionPatients in this group have received Sublobar resection. |
| Lobectomy group | – | Other: LobectomyPatients in this group have received lobectomy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with lung cancer who have received surgery.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (2 listed)
- Have previously received chemotherapy, radiotherapy and other anti-tumor therapy;
- Data loss and error in medical records due to human/objective reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sublobar resectionSublobar resection is a series of surgical approaches for lung cancer. | Other | Sublobar resection group |
| LobectomyLobectomy is the surgical approach for lung cancer. | Other | Lobectomy group |
Primary outcome
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).
4 secondary outcomes
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.
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.
Patterns of Relapse
Time frame: Within 10 years after surgery
Perioperative Complication rate
Time frame: Within 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shugeng Gao, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shugeng Gao, MD (8610-87788177, gaoshugeng@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.