Lung Cancer Associated With Cystic AirspacesNCT06699979
Multi-omics Study of Early-stage Lung Cancer With Distinct Phenotypes
An observational study of Lung Cancer Associated With Cystic Airspaces and Multiple Primary Lung Cancers, run by Central South University at 1 site in China.
Trial summary
The goal of this observational study is to investigate the multi-omics characterization early-stage lung cancer exhibiting distinct phenotypes including lung cancer associated with cystic airspaces, multiple primary lung cancers, and so on. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer Associated With Cystic Airspaces, Multiple Primary Lung Cancers, Non-Small Cell Lung Cancer
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 29 Aug 2024to 31 Dec 2027
- 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 with non-small cell lung cancer with indication for surgery.
Who may be able to join
- Male or female patients:18-75 years old;
- ECOG score:0-1;
- Histopathologically confirmed TNM stage I-II NSCLC;
- Considered multiple or solitary primary lung cancer by clinical criteria (Martini-Melamed criteria and ACCP criteria);
- Good compliance, family members agree to cooperate to receive survival follow-up;
- Understand and voluntarily sign the informed consent.
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- Male or female patients:18-75 years old;
- ECOG score:0-1;
- Histopathologically confirmed TNM stage I-II NSCLC;
- CT findings show solitary or multiple nodules with cystic airspaces.
Who cannot join
- A history of previous or co-existing malignant tumors;
- Systemic anti-tumor therapies, including chemotherapy, radiotherapy, or targeted therapies (such as monoclonal antibodies, small-molecule tyrosine kinase inhibitors, among others), were administered prior to enrollment;
- Refusal to participate in the study.
- Cohort 2: Multi-omics study of lung cancer associated with cystic airspaces
- A history of previous or co-existing malignant tumors;
- Systemic anti-tumor therapies, including chemotherapy, radiotherapy, or targeted therapies (such as monoclonal antibodies, small-molecule tyrosine kinase inhibitors, among others), were administered prior to enrollment;
- Refusal to 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
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Ping Jiang, +8673185292476, xy2gcpjiang@163.com
About this study
Official title: Comprehensive Multi-Omics Analysis of Early-Stage Lung Cancer Exhibiting Distinct Phenotypes
The goal of this observational study is to investigate the multi-omics characterization early-stage lung cancer exhibiting distinct phenotypes including lung cancer associated with cystic airspaces, multiple primary lung cancers, and so on. The main questions it aims to answer are:
- What are the differences in pathogenesis of non-small cell lung cancer with different phenotypes explored by multi-omics?
- Whether differential genes lead to potential prognostic models and therapeutic targets? Participants will be followed up after surgery to answer prognosis: whether they have recurred, and the time to recurrence.
- Conditions
- Lung Cancer Associated With Cystic Airspaces, Multiple Primary Lung Cancers, Non-Small Cell Lung Cancer
- 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 |
|---|---|---|
| Non-small cell lung cancer | Early-stage lung cancer exhibiting distinct phenotypes including lung cancer associated with cystic airspaces, multiple primary lung cancers, and so on. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune repertoire sequencing
Measured: From enrollment to the end of surgery for 3 years
DNA methylome sequencing
Measured: From enrollment to the end of surgery for 3 years
RNA sequencing
Measured: From enrollment to the end of surgery for 3 years
Secondary outcomes (3)
Genomic sequencing
Measured: From enrollment to the end of surgery for 3 years
Metabolomics analysis
Measured: From enrollment to the end of surgery for 3 years
Radiomics analysis
Measured: From enrollment to the end of surgery for 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start29 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer Associated With Cystic AirspacesStudies 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
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Chen, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699979
- Sponsor's protocol ID
- LYEC2024-0320
- Status last verified
- Mar 2026
- First submitted
- 9 Nov 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhong WZ, Wang Q, Mao WM, Xu ST, Wu L, Shen Y, Liu YY, Chen C, Cheng Y, Xu L, Wang J, Fei K, Li XF, Li J, Huang C, Liu ZD, Xu S, Chen KN, Xu SD, Liu LX, Yu P, Wang BH, Ma HT, Yan HH, Yang XN, Zhou Q, Wu YL; ADJUVANT investigators. Gefitinib versus vinorelbine plus cisplatin as adjuvant treatment for stage II-IIIA (N1-N2) EGFR-mutant NSCLC (ADJUVANT/CTONG1104): a randomised, open-label, phase 3 study. Lancet Oncol. 2018 Jan;19(1):139-148. doi: 10.1016/S1470-2045(17)30729-5. Epub 2017 Nov 21.
PubMed 29174310
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Multi-Omics Analysis of Early-Stage Lung Cancer Exhibiting Distinct Phenotypes
- ClinicalTrials.gov ID
- NCT06699979
- Acronym / sponsor ID
- LYEC2024-0320
- Conditions
- Lung Cancer Associated With Cystic Airspaces, Multiple Primary Lung Cancers, Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Nov 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 investigate the multi-omics characterization early-stage lung cancer exhibiting distinct phenotypes including lung cancer associated with cystic airspaces, multiple primary lung cancers, and so on. The main questions it aims to answer are:
- What are the differences in pathogenesis of non-small cell lung cancer with different phenotypes explored by multi-omics?
- Whether differential genes lead to potential prognostic models and therapeutic targets? Participants will be followed up after surgery to answer prognosis: whether they have recurred, and the time to recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-small cell lung cancer | – | –Early-stage lung cancer exhibiting distinct phenotypes including lung cancer associated with cystic airspaces, multiple primary lung cancers, and so on. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-small cell lung cancer with indication for surgery.
Key inclusion criteria (10 listed)
- Male or female patients:18-75 years old;
- ECOG score:0-1;
- Histopathologically confirmed TNM stage I-II NSCLC;
- Considered multiple or solitary primary lung cancer by clinical criteria (Martini-Melamed criteria and ACCP criteria);
- Good compliance, family members agree to cooperate to receive survival follow-up;
Key exclusion criteria (7 listed)
- A history of previous or co-existing malignant tumors;
- Systemic anti-tumor therapies, including chemotherapy, radiotherapy, or targeted therapies (such as monoclonal antibodies, small-molecule tyrosine kinase inhibitors, among others), were administered prior to enrollment;
- Refusal to participate in the study.
- Cohort 2: Multi-omics study of lung cancer associated with cystic airspaces
- A history of previous or co-existing malignant tumors;
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
Immune repertoire sequencing
Time frame: From enrollment to the end of surgery for 3 years
DNA methylome sequencing
Time frame: From enrollment to the end of surgery for 3 years
RNA sequencing
Time frame: From enrollment to the end of surgery for 3 years
3 secondary outcomes
Genomic sequencing
Time frame: From enrollment to the end of surgery for 3 years
Metabolomics analysis
Time frame: From enrollment to the end of surgery for 3 years
Radiomics analysis
Time frame: From enrollment to the end of surgery for 3 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 7 Jul 2026.
- Background: PubMed 29174310Zhong WZ, Wang Q, Mao WM, Xu ST, Wu L, Shen Y, Liu YY, Chen C, Cheng Y, Xu L, Wang J, Fei K, Li XF, Li J, Huang C, Liu ZD, Xu S, Chen KN, Xu SD, Liu LX, Yu P, Wang BH, Ma HT, Yan HH, Yang XN, Zhou Q, Wu YL; ADJUVANT investigators. Gefitinib versus vinorelbine plus cisplatin as adjuvant treatment for stage II-IIIA (N1-N2) EGFR-mutant NSCLC (ADJUVANT/CTONG1104): a randomised, open-label, phase 3 study. Lancet Oncol. 2018 Jan;19(1):139-148. doi: 10.1016/S1470-2045(17)30729-5. Epub 2017 Nov 21.
- 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.
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 Associated With Cystic Airspaces and Multiple Primary Lung Cancers, run by Central South University 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 10 inclusion and 7 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 7 Jul 2026. 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 Chen Chen (+8673185295188, chenchen1981412@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune repertoire sequencing (time frame: From enrollment to the end of surgery for 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06699979, which also lists 1 linked publication.
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 7 Jul 2026.