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DNA Methylation Combined With Artificial Intelligence Imaging to Identify Lung Nodules

DNA Methylation Combined With Artificial Intelligence Imaging for Early Benign and Malignant Differentiation of Lung Nodules:an Observational,Single-center Clinical Trial(MAGIC Study)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06220305
Acronym
MAGIC
Enrollment
100
Registered
2024-01-23
Start date
2022-12-01
Completion date
2024-12-31
Last updated
2024-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer Diagnosis

Brief 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 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.

Interventions

DIAGNOSTIC_TESTDNA methylation joint AI imaging

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.

Sponsors

The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years

Inclusion criteria

* (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.

Exclusion criteria

* (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.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of early diagnosis of benign and malignant lung nodules by blood DNA methylation results combined with AI imaging10 monthsConstruction 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).

Countries

China

Contacts

Primary ContactLinfu Zhou
linfu.zhou@126.com0086-13611573618
Backup ContactYichun Wang
wangyichun8702@163.com0086-18761638702

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026