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Development and Validation of a Multimodal AI Model for Aided Diagnosis of High-risk Pulmonary Nodules Integrating cfDNA Methylation, Radiological, and Clinical Features

Development and Validation of a Multimodal AI Model for Aided Diagnosis of High-risk Pulmonary Nodules Integrating cfDNA Methylation, Radiological, and Clinical Features

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121194
Enrollment
Unknown
Registered
2026-03-26
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Adenocarcinoma in situ, minimally invasive adenocarcinoma, and invasive adenocarcinoma

Interventions

Patients with high-risk pulmonary nodules:None

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age 18-80 years; 2.Able to provide CT imaging data (in DICOM format) and radiology reports obtained within 4 weeks before surgery or biopsy. The nodule must be assessed as high-risk (Lung-RADS category 4A or higher) on imaging, and the patient must be scheduled for either: Curative-intent surgical treatment, OR Further diagnostic procedures (e.g., tissue biopsy, PET-CT, contrast-enhanced CT) to determine eligibility for curative-intent surgery; 3.Able to provide a peripheral blood sample (approximately 10 mL) collected within 1 week before surgery or biopsy. 4.Able to provide complete medical history records (including age, gender, smoking history, family history of cancer, and personal history of lung diseases); 5.Has not received any prior anti-tumor therapy (such as radiotherapy, chemotherapy, targeted therapy, immunotherapy, or surgical resection) directed at the target nodule before the blood sample and CT imaging are obtained; 6.Voluntarily participates in the study and provides written informed consent.

Exclusion criteria

Exclusion criteria: 1.History of or concurrent malignancy at other sites (e.g., breast cancer, colorectal cancer); 2.Has undergone major surgery, experienced significant trauma, received a blood transfusion, or had an active infection within the past 3 months; 3.Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Benign and malignant pulmonary nodules.;

Countries

China

Contacts

Public ContactJixian Liu

Peking University Shenzhen Hospital

252110465@qq.com+86 755 83923333

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 4, 2026