DNA Methylation Combined With Artificial Intelligence Imaging to Identify Lung Nodules

NCT ID: NCT06220305

Last Updated: 2024-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer Diagnosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Pulmonary Nodule Group

patient conform pulmonary nodules on CT images

DNA methylation joint AI imaging

Intervention Type 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.

Interventions

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DNA 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Linfu Zhou

Role: CONTACT

0086-13611573618

Yichun Wang

Role: CONTACT

0086-18761638702

Facility Contacts

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Linfu Zhou

Role: primary

+8613611573618

Other Identifiers

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2023SR257

Identifier Type: -

Identifier Source: org_study_id

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