Non-small Cell Lung CancerNCT05352035
Multiomics Tumor Evolution Model of NSCLC
An observational study of Non-small Cell Lung Cancer, run by Peking University People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine the evolutionary mechanism of early-stage non-small cell lung cancer and establish an accurate prognostic model and a recurrence monitoring system by multiomics analysis, which can be helpful for the individual and whole management of lung cancer patients and improve the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2022to 31 Dec 2026
- 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: Patients who meet the eligibility criteria will be included consecutively.
Who may be able to join
- Age ≥ 18 years old;
- Early-stage NSCLC patients underwent radical surgical resection;
- Sufficient tumor tissue and blood sample for study use;
- Available clinical-pathologic data, imaging data and follow-up date;
- Written informed consent.
Who cannot join
- History of other malignant tumors;
- Evidence of distant metastasis before surgery;
- Insufficient tumor tissue or blood sample for study use;
- Clinical-pathologic data, imaging data or follow-up date is not available;
- Other judgments by the Investigator that the patient should not participate in the study.
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
Peking University People's Hospital
Beijing
Kezhong Chen, +86-010-88326657, chenkezhong@pkuph.edu.cn
Wenxiang Wang, +86-010-88326657, wangwenxiang@stu.pku.edu.cn
About this study
Official title: A Multiomics Study of Tumor Evolution Characteristics and Prognostic Model in Early-stage Non-small Cell Lung Cancer
The purpose of this study is to determine the evolutionary mechanism of early-stage non-small cell lung cancer and establish an accurate prognostic model and a recurrence monitoring system by multiomics analysis, which can be helpful for the individual and whole management of lung cancer patients and improve the overall prognosis.
Read the detailed description
Lung cancer is the leading cause of cancer-related death globally. Non-small cell lung cancer (NSCLC) accounts for 85% of lung cancer and surgery is still the main treatment strategy. This study will determine the evolutionary mechanism of early-stage non-small cell lung cancer and establish an accurate prognostic model and a recurrence monitoring system by multiomics analysis, which can be helpful for the individual and whole management of lung cancer patients and improve the overall prognosis.
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer, Multiomics analysis, Tumor evolution, Tumor immune microenvironment, Circulating tumor DNA, Radiomics, Prognostic model
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
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 |
|---|---|---|
| Prospective cohort | This cohort will enroll a total of 300 patients prospectively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
Time from randomization to disease recurrence or death from any cause.
Measured: Through study completion, an average of 2 years
Overall survival (OS)
Time from randomization to death from any cause.
Measured: Through study completion, an average of 2 years
Secondary outcomes (1)
Relationship between translational biomarkers and clinical outcome
To evaluate if the translational biomarkers can be prediction tools for the clinical outcomes.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start20 Apr 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences
- Responsible party
- Principal investigator, Jun Wang, Peking University People's Hospital
- Investigators
- Jun Wang, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352035
- Sponsor's protocol ID
- 2021-I2M-5-002
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2022
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiomics Study of Tumor Evolution Characteristics and Prognostic Model in Early-stage Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05352035
- Acronym / sponsor ID
- 2021-I2M-5-002
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer, Multiomics analysis, Tumor evolution, Tumor immune microenvironment, Circulating tumor DNA, Radiomics, Prognostic model
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Apr 2022 (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 purpose of this study is to determine the evolutionary mechanism of early-stage non-small cell lung cancer and establish an accurate prognostic model and a recurrence monitoring system by multiomics analysis, which can be helpful for the individual and whole management of lung cancer patients and improve the overall prognosis.
Detailed description
Lung cancer is the leading cause of cancer-related death globally. Non-small cell lung cancer (NSCLC) accounts for 85% of lung cancer and surgery is still the main treatment strategy. This study will determine the evolutionary mechanism of early-stage non-small cell lung cancer and establish an accurate prognostic model and a recurrence monitoring system by multiomics analysis, which can be helpful for the individual and whole management of lung cancer patients and improve the overall prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | – | –This cohort will enroll a total of 300 patients prospectively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet the eligibility criteria will be included consecutively.
Key inclusion criteria (5 listed)
- Age ≥ 18 years old;
- Early-stage NSCLC patients underwent radical surgical resection;
- Sufficient tumor tissue and blood sample for study use;
- Available clinical-pathologic data, imaging data and follow-up date;
- Written informed consent.
Key exclusion criteria (5 listed)
- History of other malignant tumors;
- Evidence of distant metastasis before surgery;
- Insufficient tumor tissue or blood sample for study use;
- Clinical-pathologic data, imaging data or follow-up date is not available;
- Other judgments by the Investigator that the patient should not participate in the study.
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
Disease-free survival (DFS)
Time frame: Through study completion, an average of 2 years
Time from randomization to disease recurrence or death from any cause.
Overall survival (OS)
Time frame: Through study completion, an average of 2 years
Time from randomization to death from any cause.
1 secondary outcome
Relationship between translational biomarkers and clinical outcome
Time frame: Through study completion, an average of 2 years
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 30 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
Jun Wang study chair
Peking University People's Hospital
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 Non-small Cell Lung Cancer, run by Peking University People's Hospital 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 5 inclusion and 5 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 30 Apr 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 Kezhong Chen, M.D. (+86-010-88326657, chenkezhong@pkuph.edu.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: Through study completion, an average of 2 years). The study lists 2 primary outcomes in all. 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 30 Apr 2025.