Lung CancerNCT05432128
To Establish a Molecular Typing System for Early Diagnosis of Lung Cancer
An observational study of Lung Cancer, run by Singlera Genomics Inc. at 1 site in China.
Trial summary
This topic to take large multicenter study real world, the advanced liquid biopsy will ctDNA methylation detection technique is applied to pulmonary nodules differential diagnosis and early lung cancer screening, validation of early lung cancer screening and diagnosis of molecular classification system model, the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 600 patients who were newly diagnosed with pulmonary nodules confirmed by chest CT
Who may be able to join
- Patients with pulmonary nodules confirmed by chest CT are not limited to single nodules;
- Nodule diameter 5-30mm
- Nodules include solid, semi-solid and ground glass nodules;
- Age 18-75, no gender limitation;
- The newly diagnosed patients did not receive surgery, radiotherapy, chemotherapy, targeted therapy or other tumor-related interventions;
- Sign informed consent.
Who cannot join
- Patients with diagnosed lung cancer and extrapulmonary malignant tumor;
- Pulmonary sarcoidosis, pulmonary vasculitis, pulmonary tuberculosis;
- Patients with poor compliance are expected to be unable to complete follow-up according to the study protocol;
- Major trauma requiring blood transfusion occurred within one week before enrollment;
- Pregnant and lactation patients.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Meng Yang, Bachelor, 18618307980, 1943826591@qq.com
Sinan Wu, 13810293738, tks0423@hotmail.com
About this study
Official title: Molecular Typing System for Early Screening and Diagnosis of Lung Cancer Combined With Liquid Biopsy Technology
This topic to take large multicenter study real world, the advanced liquid biopsy will ctDNA methylation detection technique is applied to pulmonary nodules differential diagnosis and early lung cancer screening, validation of early lung cancer screening and diagnosis of molecular classification system model, the feasibility of the development of early lung cancer screening and diagnosis of molecular classification system, improve its early screening early detection accuracy and efficiency, Improve the survival status of lung cancer high-risk population. At the same time, this project combined AI analysis technology of LDCT image results with ctDNA methylation detection, so as to overcome false negatives caused by the deficiency of ctDNA methylation detection technology in sensitivity, specificity, stability and flux, and correct false positive results that may be caused by AI analysis technology of LDCT image results. The combination of the two can avoid missed diagnosis and over - examination and over - treatment.
Read the detailed description
- All patients underwent low-dose CT pulmonary nodule AI detection and peripheral blood ctDNA methylation detection at baseline
- Follow-up plan: Low-risk and medium-risk nodules and some high-risk nodules (5-10mm) were followed up. 10ml peripheral blood was collected from each follow-up and stored for testing until the end of the study. The high-risk nodules over 10mm were evaluated by the expert group and the patients were informed by biopsy or surgical resection. Histopathological diagnosis was made and compared with ctDNA methylation results to analyze the sensitivity and specificity of ctDNA methylation markers of lung cancer.
- Endpoint: Tissue samples were pathologically diagnosed as benign or malignant.
- Conditions
- Lung Cancer
- Keywords
- ctDNA methylation, AI analysis of LDCT images
- 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 |
|---|---|---|
| Low-risk group | Combined with AI calculation of malignant probability and ctDNA methylation results, patients were divided into three groups. The high probability of malignancy calculated by AI was defined as positive, and vice versa. The methylation markers detected in specific peripheral blood of lung cancer were defined as positive, and vice versa. Negative for both items was considered as low risk group. Follow-up was conducted according to The Chinese Expert Consensus on the Diagnosis and Treatment of Pulmonary Nodules (2018 edition). 10ml peripheral blood was collected from each follow-up and stored for testing until the end of the study. | |
| medium-risk group | As above, one positive patient was considered to be in the medium-risk group and was reexamined every 6 months, with a total of 3 reexaminations expected | |
| High-risk group | Same as above, both positive are considered high-risk group.Part of high-risk nodules (5-10mm) will be reviewed every 3 months for the above two examinations, which is expected to be reviewed 6 times in total. Biopsy or surgical resection of high-risk nodules over 10mm will be performed after evaluation by the expert group and the patient's knowledge, and histopathological diagnosis will be made and compared with ctDNA methylation results. To analyze the sensitivity and specificity of ctDNA methylation markers in lung cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop a molecular typing system for early screening and diagnosis of lung cancer
The feasibility of the molecular typing system model for early screening and diagnosis of lung cancer was verified through clinical studies, which significantly improved the accuracy and efficiency of early screening and early diagnosis, and improved the survival status of high-risk population of lung cancer.
Measured: assessed up to 36 months
AI technology was combined with ctDNA methylation detection technology
In addition to overcoming false negatives caused by deficiencies in sensitivity, specificity, stability and flux of ctDNA methylation detection technology, and correcting false positive results that may be caused by AI, the combination of the two can avoid missed diagnosis, over-examination and over-treatment.
Measured: assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start1 Jan 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singlera Genomics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- China-Japan Friendship Hospital
- Responsible party
- Sponsor
- Investigators
- Rui Liu, Doctor, Principal investigator, Singlera Genomics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432128
- Sponsor's protocol ID
- 2019YFC1315803
- Status last verified
- Apr 2024
- First submitted
- 20 Jun 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang M, Yu H, Feng H, Duan J, Wang K, Tong B, Zhang Y, Li W, Wang Y, Liang C, Sun H, Zhong D, Wang B, Chen H, Gong C, He Q, Su Z, Liu R, Zhang P. Enhancing the differential diagnosis of small pulmonary nodules: a comprehensive model integrating plasma methylation, protein biomarkers, and LDCT imaging features. J Transl Med. 2024 Oct 31;22(1):984. doi: 10.1186/s12967-024-05723-5.
PubMed 39482707
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Typing System for Early Screening and Diagnosis of Lung Cancer Combined With Liquid Biopsy Technology
- ClinicalTrials.gov ID
- NCT05432128
- Acronym / sponsor ID
- 2019YFC1315803
- Conditions
- Lung Cancer
- Keywords
- ctDNA methylation, AI analysis of LDCT images
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Singlera Genomics Inc.Industry (pharma, biotech, devices)
- Collaborators
- China-Japan Friendship Hospital
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Jun 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.
This topic to take large multicenter study real world, the advanced liquid biopsy will ctDNA methylation detection technique is applied to pulmonary nodules differential diagnosis and early lung cancer screening, validation of early lung cancer screening and diagnosis of molecular classification system model, the feasibility of the development of early lung cancer screening and diagnosis of molecular classification system, improve its early screening early detection accuracy and efficiency, Improve the survival status of lung cancer high-risk population. At the same time, this project combined AI analysis technology of LDCT image results with ctDNA methylation detection, so as to overcome false negatives caused by the deficiency of ctDNA methylation detection technology in sensitivity, specificity, stability and flux, and correct false positive results that may be caused by AI analysis technology of LDCT image results. The combination of the two can avoid missed diagnosis and over - examination and over - treatment.
Detailed description
- All patients underwent low-dose CT pulmonary nodule AI detection and peripheral blood ctDNA methylation detection at baseline
- Follow-up plan: Low-risk and medium-risk nodules and some high-risk nodules (5-10mm) were followed up. 10ml peripheral blood was collected from each follow-up and stored for testing until the end of the study. The high-risk nodules over 10mm were evaluated by the expert group and the patients were informed by biopsy or surgical resection. Histopathological diagnosis was made and compared with ctDNA methylation results to analyze the sensitivity and specificity of ctDNA methylation markers of lung cancer.
- Endpoint: Tissue samples were pathologically diagnosed as benign or malignant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-risk group | – | –Combined with AI calculation of malignant probability and ctDNA methylation results, patients were divided into three groups. The high probability of malignancy calculated by AI was defined as positive, and vice versa. The methylation markers detected in specific peripheral blood of lung cancer were defined as positive, and vice versa. Negative for both items was considered as low risk group. Follow-up was conducted according to The Chinese Expert Consensus on the Diagnosis and Treatment of Pulmonary Nodules (2018 edition). 10ml peripheral blood was collected from each follow-up and stored for testing until the end of the study. |
| medium-risk group | – | –As above, one positive patient was considered to be in the medium-risk group and was reexamined every 6 months, with a total of 3 reexaminations expected |
| High-risk group | – | –Same as above, both positive are considered high-risk group.Part of high-risk nodules (5-10mm) will be reviewed every 3 months for the above two examinations, which is expected to be reviewed 6 times in total. Biopsy or surgical resection of high-risk nodules over 10mm will be performed after evaluation by the expert group and the patient's knowledge, and histopathological diagnosis will be made and compared with ctDNA methylation results. To analyze the sensitivity and specificity of ctDNA methylation markers in lung cancer. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 600 patients who were newly diagnosed with pulmonary nodules confirmed by chest CT
Key inclusion criteria (6 listed)
- Patients with pulmonary nodules confirmed by chest CT are not limited to single nodules;
- Nodule diameter 5-30mm
- Nodules include solid, semi-solid and ground glass nodules;
- Age 18-75, no gender limitation;
- The newly diagnosed patients did not receive surgery, radiotherapy, chemotherapy, targeted therapy or other tumor-related interventions;
Key exclusion criteria (5 listed)
- Patients with diagnosed lung cancer and extrapulmonary malignant tumor;
- Pulmonary sarcoidosis, pulmonary vasculitis, pulmonary tuberculosis;
- Patients with poor compliance are expected to be unable to complete follow-up according to the study protocol;
- Major trauma requiring blood transfusion occurred within one week before enrollment;
- Pregnant and lactation patients.
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
To develop a molecular typing system for early screening and diagnosis of lung cancer
Time frame: assessed up to 36 months
The feasibility of the molecular typing system model for early screening and diagnosis of lung cancer was verified through clinical studies, which significantly improved the accuracy and efficiency of early screening and early diagnosis, and improved the survival status of high-risk population of lung cancer.
AI technology was combined with ctDNA methylation detection technology
Time frame: assessed up to 36 months
In addition to overcoming false negatives caused by deficiencies in sensitivity, specificity, stability and flux of ctDNA methylation detection technology, and correcting false positive results that may be caused by AI, the combination of the two can avoid missed diagnosis, over-examination and over-treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Derived from this study: PubMed 39482707Yang M, Yu H, Feng H, Duan J, Wang K, Tong B, Zhang Y, Li W, Wang Y, Liang C, Sun H, Zhong D, Wang B, Chen H, Gong C, He Q, Su Z, Liu R, Zhang P. Enhancing the differential diagnosis of small pulmonary nodules: a comprehensive model integrating plasma methylation, protein biomarkers, and LDCT imaging features. J Transl Med. 2024 Oct 31;22(1):984. doi: 10.1186/s12967-024-05723-5.
- 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. This study is not recruiting at the moment.
Rui Liu, Doctor principal investigator
Singlera Genomics Inc.
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, run by Singlera Genomics Inc. 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 6 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: status not confirmed, as of the sponsor's last update on 17 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meng Yang, Bachelor (18618307980, 1943826591@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To develop a molecular typing system for early screening and diagnosis of lung cancer (time frame: assessed up to 36 months). 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?
On the ClinicalTrials.gov record for NCT05432128, 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 17 Apr 2024.