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A Multicenter Clinical Study on a Stratified Diagnostic Model for Pulmonary Nodules Integrating CT Imaging and Multi-Omics Liquid Biopsy

A Multicenter Clinical Study on a Stratified Diagnostic Model for Pulmonary Nodules Integrating CT Imaging and Multi-Omics Liquid Biopsy

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500104146
Enrollment
Unknown
Registered
2025-06-11
Start date
2025-06-16
Completion date
Unknown
Last updated
2025-06-16

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

Conditions

Lung nodules

Interventions

Gold Standard:Clinical pathology examination
Index test:Imageomics-based automatic recognition combined with multi-omics and liquid biopsy for diagnosis

Sponsors

The Second Affiliated Hospital of the Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subjects with pulmonary nodules, including benign nodules/pure ground-glass nodules (pGGN)/part-solid nodules (mGGN)/solid nodules; 2. Surgical or biopsy tissue specimens with pathological confirmation; 3. Pulmonary nodule diameter = 18 years; 5. Complete clinical records and clear diagnosis; 6. Willingness to sign informed consent;

Exclusion criteria

Exclusion criteria: 1. Patients with other malignancies occurring within the past 3 years; 2. Unresectable surgery (except benign nodules); 3. Patients with other treatments such as neoadjuvant therapy before surgery; 4. Patients with HIV, HBV, HCV, syphilis and other infections; 5. Patients without preoperative blood specimens or with unacceptable preoperative blood specimens. 6. History of allogeneic blood transfusion within six months prior to surgery. 7. Pregnant or lactating women; 8. History of bone marrow transplantation or cell transplantation;

Design outcomes

Primary

MeasureTime frame
Specificity;Clinical Impact Curve, CIC;Sensitivity;Clinical Decision Curve Analysis, DCA;Receiver Operating Characteristic curve;

Countries

China

Contacts

Public ContactJigang Dai

The Second Affiliated Hospital of the Army Medical University

daijigang@tmmu.edu.cn+86 13983122867

Outcome results

None listed

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