DNA Methylation Combined With Artificial Intelligence Imaging to Identify Lung Nodules

NCT06220305 | Unknown

• 1 other identifier: 2023SR257
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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).

  10 months

Study Arms (1)

Pulmonary Nodule Group

patient conform pulmonary nodules on CT images

Diagnostic Test: DNA methylation joint AI imaging

Interventions

DNA methylation joint AI imaging DIAGNOSTIC_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.

Pulmonary Nodule Group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with single pulmonary nodule found by CT scan.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

Central Study Contacts

Linfu Zhou

CONTACT

0086-13611573618; linfu.zhou@126.com

Yichun Wang

CONTACT

0086-18761638702; wangyichun8702@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: January 23, 2024
• Study Start: December 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)