Lung CancerNCT07375979
A Multi-modal Integrating Imaging and Cell-free DNA Methylation in Lung Cancer Early Detection (CMe-Lung): a Multi-center, Observational Study
An observational study of Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 7 sites in China.
Trial summary
This study is a multi-center, observational study aiming to develop an early screening multi-model for detecting lung cancer signals through the integration of imaging (non-contrast CT) and blood testing (cfDNA methylation). Read more about this study
- Who is it for?
- Ages 40 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- How many people
- 14,300 participants
- Where
- 7 sitesChina
- Study dates
- 5 Feb 2026to 1 Sep 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 40 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: lung cancers or healthy individuals who can provide imaging data meeting the inclusion and exclusion criteria
Who may be able to join
- 40-74 years old
- Clinically and/or pathologically diagnosed cancer
- No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
- Able to provide a written informed consent and willing to comply with all part of the protocol procedures
- 40-74 years old
- Without confirmed cancer diagnosis
- Able to provide a written informed consent and willing to comply with all part of the protocol procedures
Who cannot join
- Pregnancy or lactating women
- Known prior or current diagnosis of other types of malignancies comorbidities
- Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.5 °C) within 14 days prior to screen
- Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
- Recipients of blood transfusion within 30 days prior to screen
- Recipients of therapy in past 14 days prior to screen, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
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- Unsuitable for this trial determined by the researchers
- Low-quality samples: images only partially showing the lungs or in lateral decubitus position, unreadable due to severe motion artifacts/metal artifacts, or with missing critical metadata
- Pregnancy or lactating women
- Known prior or current diagnosis of other types of malignancies comorbidities
- Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.5 °C) within 14 days prior to screen
- Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
- Recipients of blood transfusion within 30 days prior to screen
- Recipients of therapy in the past 14 days prior to screen, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
- Unsuitable for this trial determined by the researchers
- Low-quality samples: images only partially showing the lungs or in lateral decubitus position, unreadable due to severe motion artifacts/metal artifacts, or with missing critical metadata
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites
The First Hospital of Ji Lin University
Changchun, Jilin, 130021
Dan Tong, 86-15843073226, tongdan@jlu.edu.cn
Yunnan Cancer Hospital
Kunming, Yunnan, 650100
Xudong Xiang, M.D., 86-13108519813, xxd9813@163.com
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200000
Chang Chen, MD,PhD, 86+13816869003, chenthoracic@163.com
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Zhigang Li, PhD, 86-18930619260, zhigang.li@shchest.org
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110801
Hongxu Liu, PhD, 86-18040097698, hongxuliu@qq.com
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, 050026
Tianlong Huo, 86-18600682228, huotianlong@bjmu.edu.cn
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Xiangnan Li, PhD, 86+13592502553, lxn-2000@163.com
About this study
This study is a multi-center, observational study aiming to develop an early screening multi-model for detecting lung cancer signals through the integration of imaging (non-contrast CT) and blood testing (cfDNA methylation).
Read the detailed description
This study aims to develop three modality -based models for lung cancer early screening, incuding a CT-based imaging model, a blood-based cfDNA methylation model, and a multimodal framework. First, 10,700 retrospective non-contrast CT scans will be collected to construct the CT imaging-based model. This model will extract multi- scale structural features through a hierarchical modeling framework, enabling the learning of interpretable spatial representations. Second, cfDNA methylation data from lung cancer patients and healthy individuals enrolled in the ProFound study (NCT06217900) wll be used to develop the blood-based model. Third, subjects with paired CT imaging and cfDNA methylation data from the ProFound study will be included to construct a multimodal model by integrating information across modalities. The performance of models based on different modalities will be systematically compared to evaluate their respective and complementary contributions to lung cancer early screening.
- Conditions
- Lung Cancer
- Keywords
- multi-modal, CT and cfDNA methylation, lung cancer early detection
- Medical subject headings
- Lung Neoplasms
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 |
|---|---|---|
| CT cohort | Lung cancer patients or healthy individuals who can provide CT scan | |
| Blood-based cohort | Blood based cfDNA methylation information retrieved from Profound study | |
| Multi-modal cohort | Retrospective collect paired CT and blood based cfDNA methylation information from Profound study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The performance of mult-modal in lung cancer early detection
The sensitivity, specificity and AUC for lung cancer early detection in detecting cancer or non-cancer at 95% confidence interval
Measured: 12 months
Secondary outcomes (2)
The performance of multi-modal across subgroup analysis
Sensitivity and 95% confidence intervals of multimodal approach (imaging combined with blood-based methylation testing) across different stages, pathological subtypes, gender, age, and risk factor subgroups.
Measured: 12 months
Comparing the performance of three different modals.
Comparison of sensitivity, specificity, and 95% confidence intervals among imaging modality, blood-based methylation testing modality, and multimodal approach (imaging combined with blood-based methylation testing) in lung cancer early screening.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start5 Feb 2026 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Sep 2026 (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.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 14,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Chest Hospital, Liaoning Cancer Hospital & Institute, The First Affiliated Hospital of Zhengzhou University, Yunnan Cancer Hospital, Shijiazhuang People's Hospital, The First Hospital of Jilin University
- Responsible party
- Principal investigator, Chang Chen, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375979
- Sponsor's protocol ID
- CMe-Lung
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-modal Integrating Imaging and Cell-free DNA Methylation in Lung Cancer Early Detection (CMe-Lung): a Multi-center, Observational Study
- ClinicalTrials.gov ID
- NCT07375979
- Acronym / sponsor ID
- CMe-Lung
- Conditions
- Lung Cancer
- Keywords
- multi-modal, CT and cfDNA methylation, lung cancer early detection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 14,300 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Collaborators
- Shanghai Chest Hospital, Liaoning Cancer Hospital & Institute, The First Affiliated Hospital of Zhengzhou University, Yunnan Cancer Hospital, Shijiazhuang People's Hospital, The First Hospital of Jilin University
- Study start
- 5 Feb 2026 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 29 Jan 2026 (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 study aiming to develop an early screening multi-model for detecting lung cancer signals through the integration of imaging (non-contrast CT) and blood testing (cfDNA methylation).
Detailed description
This study aims to develop three modality -based models for lung cancer early screening, incuding a CT-based imaging model, a blood-based cfDNA methylation model, and a multimodal framework. First, 10,700 retrospective non-contrast CT scans will be collected to construct the CT imaging-based model. This model will extract multi- scale structural features through a hierarchical modeling framework, enabling the learning of interpretable spatial representations. Second, cfDNA methylation data from lung cancer patients and healthy individuals enrolled in the ProFound study (NCT06217900) wll be used to develop the blood-based model. Third, subjects with paired CT imaging and cfDNA methylation data from the ProFound study will be included to construct a multimodal model by integrating information across modalities. The performance of models based on different modalities will be systematically compared to evaluate their respective and complementary contributions to lung cancer early screening.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CT cohort | – | –Lung cancer patients or healthy individuals who can provide CT scan |
| Blood-based cohort | – | –Blood based cfDNA methylation information retrieved from Profound study |
| Multi-modal cohort | – | –Retrospective collect paired CT and blood based cfDNA methylation information from Profound study |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- lung cancers or healthy individuals who can provide imaging data meeting the inclusion and exclusion criteria
Key inclusion criteria (7 listed)
- 40-74 years old
- Clinically and/or pathologically diagnosed cancer
- No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
- Able to provide a written informed consent and willing to comply with all part of the protocol procedures
- 40-74 years old
Key exclusion criteria (16 listed)
- Pregnancy or lactating women
- Known prior or current diagnosis of other types of malignancies comorbidities
- Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.5 °C) within 14 days prior to screen
- Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
- Recipients of blood transfusion within 30 days prior to screen
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
The performance of mult-modal in lung cancer early detection
Time frame: 12 months
The sensitivity, specificity and AUC for lung cancer early detection in detecting cancer or non-cancer at 95% confidence interval
2 secondary outcomes
The performance of multi-modal across subgroup analysis
Time frame: 12 months
Comparing the performance of three different modals.
Time frame: 12 months
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 Jan 2026.
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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.
7 sites 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 Shanghai Pulmonary Hospital, Shanghai, China at 7 sites 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 16 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: opening soon, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The performance of mult-modal in lung cancer early detection (time frame: 12 months). 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 Jan 2026.