Lung CancerNCT06255197
Characteristics, Treatment Patterns and Outcomes for Patients With Surgically Resected Lung Cancers
An observational study of Lung Cancer and Lung Adenocarcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study is a multi-center, observational, real-world study for patients with resected lung cancers in China. With the help of a properly designed data processing algorithm and extensively performed data quality assurance, this study aims to harness the potential of real-world big data to (1) describe… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lung Adenocarcinoma, Lung Squamous Cell Carcinoma
- How many people
- 60,000 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2019to 31 Dec 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants eligible for this study would be screened from consecutive patients who received surgical resection for lung malignancies in participating medical centers during the designed study period.
Who may be able to join
- Age above 18.
- Have received surgical resection for lung malignancies.
Who cannot join
- Participants whose data are of low quality, poor completeness or poor internal linkage.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Renda Li, MD contact
China1 site, 1 recruiting
- Recruiting
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Fengwei Tan, MD, 010-87787790, tanfengwei@126.com
About this study
This study is a multi-center, observational, real-world study for patients with resected lung cancers in China. With the help of a properly designed data processing algorithm and extensively performed data quality assurance, this study aims to harness the potential of real-world big data to (1) describe characteristics and treatment patterns and their evolving trends; (2) discover features associated with overall survival; and (3) address recently-emerging clinical questions.
Read the detailed description
Lung cancer is the leading cause of cancer-related deaths in China. The recent decade witnessed rapid evolving of demographics, pathological features and prognoses of patients with surgically resected lung cancers. The introduction of minimally invasive surgery (MIS) concept and techniques, targeted therapy and immunotherapy changed treatment landscape for patients with surgically resected lung cancers. With more early-stage lung cancers discovered due to the application of CT screening, questions focusing on extent of lung resection, lymph node dissection, application of targeted or immune-therapy to early-stage lung cancers are emerging. This study aims to create a cohort of patients with surgically resected lung cancers and an analytic framework to address the aforementioned clinical questions.
- Conditions
- Lung Cancer, Lung Adenocarcinoma, Lung Squamous Cell Carcinoma, Non Small Cell Lung Cancer, Small-cell Lung Cancer
- Keywords
- Lung cancer, Surgery, Real world
- Medical subject headings
- Lung Neoplasms, Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with surgically resected lung cancer | Patients who were diagnosed with lung cancer and received surgical resection in participating medical centers during the designed study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time from surgery to death from any cause.
Measured: January 2014 to December 2031
Secondary outcomes (4)
Baseline characteristics of included participants
Demographics, symptoms at diagnosis, tobacco exposure, family history, previous medical history, etc.
Measured: January 2014 to December 2028
Treatment patterns of included participants
Extent of lung resection and lymph node dissection, application of certain surgical techniques or not; application of chemotherapy, targeted therapy, immunotherapy and/or radiotherapy before and/or after surgery.
Measured: January 2014 to December 2028
Pathological characteristics of included participants
Location, size, classification, presence or absence of certain pathological features of resected tumor(s); number of metastasized and dissected lymph nodes in each station.
Measured: January 2014 to December 2028
Features associated with overall survival
Features within the range of collected baseline characteristics, treatment patterns and pathological characteristics that are associated with overall survival.
Measured: First analysis is anticipated to be performed from April to August 2024; the final analysis is anticipated in 2032.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start4 Nov 2019
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2031 (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
- Other
- Enrolment
- 60,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie He, MD-PhD, Principal investigator, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS and PUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255197
- Sponsor's protocol ID
- LungReal_01
- Status last verified
- Jan 2024
- First submitted
- 4 Feb 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics, Treatment Patterns and Outcomes for Patients With Surgically Resected Lung Cancers
- ClinicalTrials.gov ID
- NCT06255197
- Acronym / sponsor ID
- LungReal_01
- Conditions
- Lung Cancer, Lung Adenocarcinoma, Lung Squamous Cell Carcinoma, Non Small Cell Lung Cancer, Small-cell Lung Cancer
- Keywords
- Lung cancer, Surgery, Real world
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60,000 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 13 Feb 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.
This study is a multi-center, observational, real-world study for patients with resected lung cancers in China. With the help of a properly designed data processing algorithm and extensively performed data quality assurance, this study aims to harness the potential of real-world big data to (1) describe characteristics and treatment patterns and their evolving trends; (2) discover features associated with overall survival; and (3) address recently-emerging clinical questions.
Detailed description
Lung cancer is the leading cause of cancer-related deaths in China. The recent decade witnessed rapid evolving of demographics, pathological features and prognoses of patients with surgically resected lung cancers. The introduction of minimally invasive surgery (MIS) concept and techniques, targeted therapy and immunotherapy changed treatment landscape for patients with surgically resected lung cancers. With more early-stage lung cancers discovered due to the application of CT screening, questions focusing on extent of lung resection, lymph node dissection, application of targeted or immune-therapy to early-stage lung cancers are emerging. This study aims to create a cohort of patients with surgically resected lung cancers and an analytic framework to address the aforementioned clinical questions.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with surgically resected lung cancer | – | –Patients who were diagnosed with lung cancer and received surgical resection in participating medical centers during the designed study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants eligible for this study would be screened from consecutive patients who received surgical resection for lung malignancies in participating medical centers during the designed study period.
Key inclusion criteria (2 listed)
- Age above 18.
- Have received surgical resection for lung malignancies.
Key exclusion criteria (1 listed)
- Participants whose data are of low quality, poor completeness or poor internal linkage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: January 2014 to December 2031
Time from surgery to death from any cause.
4 secondary outcomes
Baseline characteristics of included participants
Time frame: January 2014 to December 2028
Treatment patterns of included participants
Time frame: January 2014 to December 2028
Pathological characteristics of included participants
Time frame: January 2014 to December 2028
Features associated with overall survival
Time frame: First analysis is anticipated to be performed from April to August 2024; the final analysis is anticipated in 2032.
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 16 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Renda Li, MD contact
Jie He, MD-PhD principal investigator
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS and PUMC
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 and Lung Adenocarcinoma, 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 2 inclusion and 1 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 16 Feb 2024. 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 Fengwei Tan, MD-PhD (+8601087787792, tanfengwei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: January 2014 to December 2031). 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 16 Feb 2024.