Lung Cancer (NSCLC)NCT07257471
Application Research of Methylation Markers in Early-stage Lung Cancer Patients Treated With Co-ablation System Therapy
An observational study of Lung Cancer (NSCLC), run by Beijing Haidian Hospital at 1 site in China.
Trial summary
Lung cancer has the highest global incidence and mortality among malignancies. While surgery is the primary curative treatment for early-stage patients, approximately 25-35% are ineligible due to comorbidities. For these patients, Co-ablation system therapy is a key minimally invasive option. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Cancer (NSCLC)
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2025to 30 Jun 2028
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with non-small cell lung cancer (NSCLC) diagnosed by histopathology/clinical diagnosis and scheduled for Co-ablation system therapy were selected, with ages ranging from 18 to 85 years old. All enrolled patients had peripheral blood drawn within one week before treatment, and at 3 days, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months after treatment for the detection of SHOX2/PTGER4 methylation in plasma circulating tumor DNA (ctDNA).
Who may be able to join
- Diagnosed with non-small cell lung cancer by histopathology/clinical diagnosis; assessed by MDT as not suitable or refusing open or thoracoscopic resection surgery.
- Age 18-85 years old, gender unrestricted.
- The maximum diameter of the tumor is ≤ 5 cm (peripheral type) or ≤ 3 cm (central type), and the distance from major blood vessels/trachea is ≥ 1 cm.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1, with an expected survival period of ≥ 6 months.
- The subjects should have clear case information, including age, gender, and clinical diagnosis, etc.
Who cannot join
- Those with a history of other malignant tumors or autoimmune diseases。
- Pregnant or lactating women; or patients with lung cancer who were negative for methylation before treatment.
- Patients with clinical or pathological diagnosis of lung metastatic cancer.
- Ppatients with multiple nodules and the current treatment cannot completely address all positive nodules.
- Patients whose clinical information or follow-up during the study may not be completed; and other factors that the researcher deems unsuitable for participation in this 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
Beijing Haidian Hospital
Beijing, Beijing Municipality, 100080
Yuqing Huang, Ph.D, +86 13371735630, huangyuqing555@qq.com
About this study
Lung cancer has the highest global incidence and mortality among malignancies. While surgery is the primary curative treatment for early-stage patients, approximately 25-35% are ineligible due to comorbidities. For these patients, Co-ablation system therapy is a key minimally invasive option. However, even after imaging indicates complete tumor removal ("tumor-free status"), minimal residual disease (MRD) may persist, leading to recurrence.
Current mainstream MRD detection relies on identifying mutations in circulating tumor DNA (ctDNA). This approach faces challenges like high mutational heterogeneity and the frequent need for tumor tissue sequencing (Tumor-informed). In contrast, DNA methylation markers offer advantages: they do not require prior knowledge of tumor mutations, appear early in tumorigenesis, are tissue-specific, and allow sensitive detection via multiple consistent CpG sites. Recent studies confirm that ctDNA methylation-based MRD detection can predict recurrence in lung and colorectal cancers earlier than imaging and effectively stratify patient risk.
This study aims to investigate the role of SHOX2 and PTGER4 genes in plasma, for monitoring MRD and evaluating therapeutic efficacy in lung cancer patients after Co-ablation system therapy. The study will enroll non-small cell lung cancer (NSCLC) patients undergoing Co-ablation system therapy. Peripheral blood will be collected at multiple timepoints (pre-treatment up to 24 months post-treatment) for ctDNA methylation analysis. The correlation between methylation levels and radiological findings will be assessed. The predictive power for recurrence will be evaluated using ROC curves. Patients will be stratified into high-risk and low-risk groups based on methylation status. Kaplan-Meier survival analysis and Cox regression models will compare recurrence-free survival between groups and evaluate the independent predictive value of SHOX2/PTGER4 methylation for recurrence risk, providing a scientific basis for personalized treatment decisions and recurrence prediction.
Read the detailed description
Lung cancer is one of the major malignant tumors threatening human life and health, with its incidence and mortality rates consistently ranking first among all malignant tumors globally. China has a high incidence of lung cancer. According to the latest data released by the National Cancer Center, in 2022, there were 1,060,600 new cases of lung cancer in China, accounting for 22.0% of all new malignant tumor cases, and 733,300 deaths, accounting for 28.5% of all malignant tumor deaths.
Among patients with non-small cell lung cancer (NSCLC), the risk of recurrence varies significantly across different stages: the 5-year recurrence rates are 19% for stage IA, 30% for stage IB, and 48.6% for stage II, while the 3-year recurrence rate for stage III patients is as high as 52%. Early surgical resection is the primary treatment method to improve the survival rate of lung cancer patients. As a local treatment modality, Co-ablation system therapy are particularly suitable for patients who cannot tolerate surgery or are ineligible for surgical treatment. However, postoperative recurrence and metastasis remain the core challenges in lung cancer treatment. Even when imaging examinations show that the tumor has achieved a so-called "no evidence of disease" status (R0 resection)-meaning the tumor has disappeared at the macroscopic and imaging levels-minimal residual disease (MRD) that may trigger cancer recurrence could still be hidden beneath this appearance.
Currently, mainstream MRD detection methods on the market rely on the detection of mutations in circulating tumor DNA (ctDNA). However, such mutation-based MRD detection has obvious limitations. For instance, the heterogeneity of tumor mutations among different patients is extremely high, making it difficult for small-sized detection panels to cover a broader patient population. The Tumor-inform detection approach achieves MRD detection by customizing a specific panel for each patient, but this method requires obtaining the patient's tumor tissue sample for sequencing, which to some extent limits its clinical application.
In contrast, when DNA methylation markers are used for MRD detection, there is no need to pre-obtain characteristic mutation information of the primary tumor, and the detection sensitivity is not affected by the number of high-frequency mutations in the patient's tumor. Moreover, DNA methylation modifications usually occur in the early stages of tumorigenesis and exhibit tissue specificity and cancer type specificity. At the same time, DNA methylation often maintains good consistency across multiple gene regions; therefore, MRD analysis can be achieved by detecting the methylation status of multiple CpG sites.
This study selected patients diagnosed with non-small cell lung cancer through histopathology or clinical diagnosis, all of whom underwent Co-ablation system therapy. Peripheral blood samples were collected from all enrolled patients at 3 days, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months after treatment for SHOX2/PTGER4 gene methylation detection. The study aims to explore whether this gene methylation detection can serve as an effective indicator for dynamic MRD monitoring in lung cancer patients after Co-ablation system therapy and to analyze its clinical efficacy in lung cancer patients. It is expected to provide a scientific basis for predicting the risk of lung cancer recurrence and guiding individualized treatment decisions, thereby avoiding overtreatment or delayed treatment.
- Conditions
- Lung Cancer (NSCLC)
- Keywords
- Liquid biopsy, ctDNA, Methylation biomarker, Prognostic monitoring, MRD, Co-ablation system therapy, Therapeutic efficacy evaluation
- Medical subject headings
- Lung Neoplasms, 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 |
|---|---|---|
| Co-ablation system therapy group | Lung cancer patients are treated with Co-ablation system therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The median lead time of SHOX2/PTGER4 methylation compared with traditional methods (tumor markers, imaging) for prediction.
Measure time point of outcome: Preoperatively, 3 days, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively, and at the time of recurrence.
Measure method: SHOX2/PTGER4 Methylation Detection Kit (PCR Fluorescence Method).
Measured: Through study completion, an average of 2 years.
Disease-free survival: Differences in DFS based on methylation status after treatment.
Measure time point of outcome: Preoperatively, 3 days, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively, and at the time of recurrence.
Measure method: Kaplan-Meier method.
Measured: Through study completion, an average of 2 years.
Dynamic concentration changes: The relative change rate of methylation levels before and after treatment and during recurrence.
Measure time point of outcome: Preoperatively, 3 days, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively, and at the time of recurrence.
Measure method: SHOX2/PTGER4 Methylation Detection Kit (PCR Fluorescence Method).
Measured: Through study completion, an average of 2 years.
Secondary outcomes (3)
The rate of methylation "turning negative" after treatment
Measure time point of outcome: Preoperatively, 3 days, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively, and at the time of recurrence.
Measure method: SHOX2/PTGER4 Methylation Detection Kit (PCR Fluorescence Method).
Measured: Through study completion, an average of 2 years.
The relationship between methylation status and overall survival.
Measure time point of outcome: Preoperatively, 3 days, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively, and at the time of recurrence.
Measure method: Multivariate Cox regression, Log-rank test
Measured: Through study completion, an average of 2 years.
Forecast performance
Measure time point of outcome: Preoperatively, 3 days, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively, and at the time of recurrence.
Measure method: Receiver Operating Characteristic Curve.
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 posted2 Dec 2025
- Study start6 Jun 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Haidian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuqing Huang, Beijing Haidian Hospital
- Investigators
- Yuqing Huang, Principal investigator, Beijing Haidian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257471
- Sponsor's protocol ID
- M202552
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Research of Methylation Markers in Early-stage Lung Cancer Patients Treated With Co-ablation System Therapy
- ClinicalTrials.gov ID
- NCT07257471
- Acronym / sponsor ID
- M202552
- Conditions
- Lung Cancer (NSCLC)
- Keywords
- Liquid biopsy, ctDNA, Methylation biomarker, Prognostic monitoring, MRD, Co-ablation system therapy, Therapeutic efficacy evaluation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Haidian HospitalUniversity, hospital or other
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 2 Dec 2025 (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.
Lung cancer has the highest global incidence and mortality among malignancies. While surgery is the primary curative treatment for early-stage patients, approximately 25-35% are ineligible due to comorbidities. For these patients, Co-ablation system therapy is a key minimally invasive option. However, even after imaging indicates complete tumor removal ("tumor-free status"), minimal residual disease (MRD) may persist, leading to recurrence.
Current mainstream MRD detection relies on identifying mutations in circulating tumor DNA (ctDNA). This approach faces challenges like high mutational heterogeneity and the frequent need for tumor tissue sequencing (Tumor-informed). In contrast, DNA methylation markers offer advantages: they do not require prior knowledge of tumor mutations, appear early in tumorigenesis, are tissue-specific, and allow sensitive detection via multiple consistent CpG sites. Recent studies confirm that ctDNA methylation-based MRD detection can predict recurrence in lung and colorectal cancers earlier than imaging and effectively stratify patient risk.
This study aims to investigate the role of SHOX2 and PTGER4 genes in plasma, for monitoring MRD and evaluating therapeutic efficacy in lung cancer patients after Co-ablation system therapy. The study will enroll non-small cell lung cancer (NSCLC) patients undergoing Co-ablation system therapy. Peripheral blood will be collected at multiple timepoints (pre-treatment up to 24 months post-treatment) for ctDNA methylation analysis. The correlation between methylation levels and radiological findings will be assessed. The predictive power for recurrence will be evaluated using ROC curves. Patients will be stratified into high-risk and low-risk groups based on methylation status. Kaplan-Meier survival analysis and Cox regression models will compare recurrence-free survival between groups and evaluate the independent predictive value of SHOX2/PTGER4 methylation for recurrence risk, providing a scientific basis for personalized treatment decisions and recurrence prediction.
Detailed description
Lung cancer is one of the major malignant tumors threatening human life and health, with its incidence and mortality rates consistently ranking first among all malignant tumors globally. China has a high incidence of lung cancer. According to the latest data released by the National Cancer Center, in 2022, there were 1,060,600 new cases of lung cancer in China, accounting for 22.0% of all new malignant tumor cases, and 733,300 deaths, accounting for 28.5% of all malignant tumor deaths.
Among patients with non-small cell lung cancer (NSCLC), the risk of recurrence varies significantly across different stages: the 5-year recurrence rates are 19% for stage IA, 30% for stage IB, and 48.6% for stage II, while the 3-year recurrence rate for stage III patients is as high as 52%. Early surgical resection is the primary treatment method to improve the survival rate of lung cancer patients. As a local treatment modality, Co-ablation system therapy are particularly suitable for patients who cannot tolerate surgery or are ineligible for surgical treatment. However, postoperative recurrence and metastasis remain the core challenges in lung cancer treatment. Even when imaging examinations show that the tumor has achieved a so-called "no evidence of disease" status (R0 resection)-meaning the tumor has disappeared at the macroscopic and imaging levels-minimal residual disease (MRD) that may trigger cancer recurrence could still be hidden beneath this appearance.
Currently, mainstream MRD detection methods on the market rely on the detection of mutations in circulating tumor DNA (ctDNA). However, such mutation-based MRD detection has obvious limitations. For instance, the heterogeneity of tumor mutations among different patients is extremely high, making it difficult for small-sized detection panels to cover a broader patient population. The Tumor-inform detection approach achieves MRD detection by customizing a specific panel for each patient, but this method requires obtaining the patient's tumor tissue sample for sequencing, which to some extent limits its clinical application.
In contrast, when DNA methylation markers are used for MRD detection, there is no need to pre-obtain characteristic mutation information of the primary tumor, and the detection sensitivity is not affected by the number of high-frequency mutations in the patient's tumor. Moreover, DNA methylation modifications usually occur in the early stages of tumorigenesis and exhibit tissue specificity and cancer type specificity. At the same time, DNA methylation often maintains good consistency across multiple gene regions; therefore, MRD analysis can be achieved by detecting the methylation status of multiple CpG sites.
This study selected patients diagnosed with non-small cell lung cancer through histopathology or clinical diagnosis, all of whom underwent Co-ablation system therapy. Peripheral blood samples were collected from all enrolled patients at 3 days, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months after treatment for SHOX2/PTGER4 gene methylation detection. The study aims to explore whether this gene methylation detection can serve as an effective indicator for dynamic MRD monitoring in lung cancer patients after Co-ablation system therapy and to analyze its clinical efficacy in lung cancer patients. It is expected to provide a scientific basis for predicting the risk of lung cancer recurrence and guiding individualized treatment decisions, thereby avoiding overtreatment or delayed treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Co-ablation system therapy group | – | –Lung cancer patients are treated with Co-ablation system therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-small cell lung cancer (NSCLC) diagnosed by histopathology/clinical diagnosis and scheduled for Co-ablation system therapy were selected, with ages ranging from 18 to 85 years old. All enrolled patients had peripheral blood drawn within one week before treatment, and at 3 days, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months after treatment for the detection of SHOX2/PTGER4 methylation in plasma circulating tumor DNA (ctDNA).
Key inclusion criteria (5 listed)
- Diagnosed with non-small cell lung cancer by histopathology/clinical diagnosis; assessed by MDT as not suitable or refusing open or thoracoscopic resection surgery.
- Age 18-85 years old, gender unrestricted.
- The maximum diameter of the tumor is ≤ 5 cm (peripheral type) or ≤ 3 cm (central type), and the distance from major blood vessels/trachea is ≥ 1 cm.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1, with an expected survival period of ≥ 6 months.
- The subjects should have clear case information, including age, gender, and clinical diagnosis, etc.
Key exclusion criteria (5 listed)
- Those with a history of other malignant tumors or autoimmune diseases。
- Pregnant or lactating women; or patients with lung cancer who were negative for methylation before treatment.
- Patients with clinical or pathological diagnosis of lung metastatic cancer.
- Ppatients with multiple nodules and the current treatment cannot completely address all positive nodules.
- Patients whose clinical information or follow-up during the study may not be completed; and other factors that the researcher deems unsuitable for participation in this 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
The median lead time of SHOX2/PTGER4 methylation compared with traditional methods (tumor markers, imaging) for prediction.
Time frame: Through study completion, an average of 2 years.
Measure time point of outcome: Preoperatively, 3 days, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively, and at the time of recurrence. Measure method: SHOX2/PTGER4 Methylation Detection Kit (PCR Fluorescence Method).
Disease-free survival: Differences in DFS based on methylation status after treatment.
Time frame: Through study completion, an average of 2 years.
Measure time point of outcome: Preoperatively, 3 days, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively, and at the time of recurrence. Measure method: Kaplan-Meier method.
Dynamic concentration changes: The relative change rate of methylation levels before and after treatment and during recurrence.
Time frame: Through study completion, an average of 2 years.
Measure time point of outcome: Preoperatively, 3 days, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively, and at the time of recurrence. Measure method: SHOX2/PTGER4 Methylation Detection Kit (PCR Fluorescence Method).
3 secondary outcomes
The rate of methylation "turning negative" after treatment
Time frame: Through study completion, an average of 2 years.
The relationship between methylation status and overall survival.
Time frame: Through study completion, an average of 2 years.
Forecast performance
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 2 Dec 2025.
- 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.
Yuqing Huang principal investigator
Beijing Haidian 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 Lung Cancer (NSCLC), run by Beijing Haidian 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 2 Dec 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 Yuqing Huang, Ph.D (+86 13371735630, huangyuqing555@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The median lead time of SHOX2/PTGER4 methylation compared with traditional methods (tumor markers, imaging) for prediction. (time frame: Through study completion, an average of 2 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?
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 2 Dec 2025.