Lung Cancer DiagnosisMAGICNCT06220305
DNA Methylation Combined With Artificial Intelligence Imaging to Identify Lung Nodules
An observational study of Lung Cancer Diagnosis, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Lung cancer is the leading cause of cancer deaths,and the key to reducing mortality in lung cancer patients is early diagnosis and treatment.Currently,peripheral blood DNA methylation is a novel in vitro molecular marker for tumors.Meanwhile artificial intelligence diagnostic system can further improve the diagnostic… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Lung Cancer Diagnosis
- What is being tested?
- DNA methylation joint AI imaging
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 31 Dec 2024
- 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 20 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with single pulmonary nodule found by CT scan.
Who may be able to join
- (1) Patients with pulmonary nodules diagnosed by imaging;
- (2) No contraindications to blood collection;
- (3) Voluntary completed DNA methylation testing;
- (4) Signed informed consent and performed all the study mandated procedures.
Who cannot join
- (1) Pregnant or lactating(6 months) women;
- (2) History of malignancy or known malignancy or precancerous lesions or known tuberculosis within 3 years;
- (3) Autoimmune system disorders;
- (4) Undergoing any diagnostic puncture therapy, such as percutaneous lung biopsy, transbronchial, pre-enrollment biopsy, or surgical procedures (within 6 months); (5) Recipients of organ transplants or prior non-autologous (allogeneic) bone marrow transplants or stem cell transplants; (6) Received antibiotic therapy within 14 days or applied a drug that elevates white blood cells within 45 days prior to the blood draw.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Linfu Zhou, +8613611573618, linfu.zhou@126.com
About this study
Official title: DNA Methylation Combined With Artificial Intelligence Imaging for Early Benign and Malignant Differentiation of Lung Nodules:an Observational,Single-center Clinical Trial(MAGIC Study)
Lung cancer is the leading cause of cancer deaths,and the key to reducing mortality in lung cancer patients is early diagnosis and treatment.Currently,peripheral blood DNA methylation is a novel in vitro molecular marker for tumors.Meanwhile artificial intelligence diagnostic system can further improve the diagnostic ability.The purpose of this study is to apply the overall DNA methylation level (i.e.,methylation profile) and the altered methylation degree of specific genes as tumor diagnostic indexes,and combined with the artificial intelligence imaging technology for the early and accurate diagnosis of lung cancer,to achieve the early detection,diagnosis,and treatment of lung cancer,and to effectively reduce the mortality rate of lung cancer.
- Conditions
- Lung Cancer Diagnosis
- Being tested
- DNA methylation joint AI imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA methylation joint AI imagingDiagnostic test
DNA were extracted from patients'plasma ,then the DNA was bisulfite converted and tested by DNA methylation assay.The results were combined with AI images to differentiate between benign and malignant lung nodules.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Nodule Group | patient conform pulmonary nodules on CT images Receives: Diagnostic Test: DNA methylation joint AI imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of early diagnosis of benign and malignant lung nodules by blood DNA methylation results combined with AI imaging
Construction of a diagnostic model for DNA methylation combined with AI imaging. Comparing the results of the model with pathologic diagnosis, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Dec 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer DiagnosisStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220305
- Sponsor's protocol ID
- 2023SR257
- Acronym
- MAGIC
- Status last verified
- Jan 2024
- First submitted
- 14 Jan 2024
- Last updated
- 23 Jan 2024
- 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 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA Methylation Combined With Artificial Intelligence Imaging for Early Benign and Malignant Differentiation of Lung Nodules:an Observational,Single-center Clinical Trial(MAGIC Study)
- ClinicalTrials.gov ID
- NCT06220305
- Acronym / sponsor ID
- MAGIC / 2023SR257
- Conditions
- Lung Cancer Diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Jan 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.
Lung cancer is the leading cause of cancer deaths,and the key to reducing mortality in lung cancer patients is early diagnosis and treatment.Currently,peripheral blood DNA methylation is a novel in vitro molecular marker for tumors.Meanwhile artificial intelligence diagnostic system can further improve the diagnostic ability.The purpose of this study is to apply the overall DNA methylation level (i.e.,methylation profile) and the altered methylation degree of specific genes as tumor diagnostic indexes,and combined with the artificial intelligence imaging technology for the early and accurate diagnosis of lung cancer,to achieve the early detection,diagnosis,and treatment of lung cancer,and to effectively reduce the mortality rate of lung cancer.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Nodule Group | – | Diagnostic Test: DNA methylation joint AI imagingpatient conform pulmonary nodules on CT images |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with single pulmonary nodule found by CT scan.
Key inclusion criteria (4 listed)
- (1) Patients with pulmonary nodules diagnosed by imaging;
- (2) No contraindications to blood collection;
- (3) Voluntary completed DNA methylation testing;
- (4) Signed informed consent and performed all the study mandated procedures.
Key exclusion criteria (4 listed)
- (1) Pregnant or lactating(6 months) women;
- (2) History of malignancy or known malignancy or precancerous lesions or known tuberculosis within 3 years;
- (3) Autoimmune system disorders;
- (4) Undergoing any diagnostic puncture therapy, such as percutaneous lung biopsy, transbronchial, pre-enrollment biopsy, or surgical procedures (within 6 months); (5) Recipients of organ transplants or prior non-autologous (allogeneic) bone marrow transplants or stem cell transplants; (6) Received antibiotic therapy within 14 days or applied a drug that elevates white blood cells within 45 days prior to the blood draw.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA methylation joint AI imagingDNA were extracted from patients'plasma ,then the DNA was bisulfite converted and tested by DNA methylation assay.The results were combined with AI images to differentiate between benign and malignant lung nodules. | Diagnostic test | Pulmonary Nodule Group |
Primary outcome
Efficacy of early diagnosis of benign and malignant lung nodules by blood DNA methylation results combined with AI imaging
Time frame: 10 months
Construction of a diagnostic model for DNA methylation combined with AI imaging. Comparing the results of the model with pathologic diagnosis, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- 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.
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 Diagnosis, run by The First Affiliated Hospital with Nanjing Medical 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 4 inclusion and 4 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 23 Jan 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 Linfu Zhou (0086-13611573618, linfu.zhou@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of early diagnosis of benign and malignant lung nodules by blood DNA methylation results combined with AI imaging (time frame: 10 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 23 Jan 2024.