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Recruiting NCT06056999

New Method to Differentiate Benign and Malignant Pulmonary Nodules.

Trial Parameters

Condition Pulmonary Nodules
Sponsor China-Japan Friendship Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 150
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-09-29
Completion 2025-01

Brief Summary

The goal of this observational clinical trial is to establish a new method for differentiating benign and malignant pulmonary nodules by peripheral blood detection in patients with pulmonary nodules (\<3cm). The main questions it aims to answer is: How to combine blood metabolomic mass spectrometry detection and artificial intelligence image analysis to establish a new model for differentiating benign and malignant pulmonary nodules. Participants will be asked provide 4 mL peripheral blood for the test.

Eligibility Criteria

Inclusion Criteria: * Age ≥18 years; * CT imaging shows the presence of pulmonary nodule \<3cm which is scheduled for puncture biopsy or surgery (i.e., the target lesion), the presence of ≥2 target lesions of the same type (categorized by density) are allowed; * Subjects are in good condition with Eastern Cooperative Oncology Group (ECOG) scale of 0-2; * Subjects with fair vital organ function, defined as: white blood cells ≥3.0×10\^9/L, platelets ≥75×10\^9/L, hemoglobin ≥90g/L, alanine aminotransferase and aspartate aminotransferase ≤2.5 times the upper limit of normal values, and serum creatinine \<178μmol/L; * Subjects must have the ability to understand and sign the informed consent in writing voluntarily. Exclusion Criteria: * Imaging examination have suggested the possibility of metastasis at other sites; * ≥2 target lesions with different type categorized by density; * History of malignant disease; * Severe vascular lesions within the last 3 months, or known significant active i

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