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Clinical Trials in China / NCT06056999
Recruiting Observational

New Method to Differentiate Benign and Malignant Pulmonary Nodules.

NCT06056999 · tracked via the Priya Life Science China tracker
Sponsor
China-Japan Friendship Hospital
Phase
Observational
Started
2023-09-29
Last updated
2024-12-18

Condition(s) studied

Pulmonary Nodules

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 infection, during acute/chronic tuberculosis infection, or severe cardiovascular and cerebrovascular diseases, dysfunction of liver and renal, or significant endocrine and metabolic disorders, or other serious concomitant diseases that are not controlled; * The specialist/surgeon assessed that puncture or surgery is not available, with contraindication such as coagulation disorders, cardiorespiratory insufficiency, etc.; * History of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders, that may affect the signing of informed consent; * Pregnant or breastfeeding women; * Other conditions deemed by the investigator to be unsuitable for enrollment.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
China-Japan Friendship Hospital Beijing Beijing Municipality Recruiting

More China-Japan Friendship Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06056999 on ClinicalTrials.gov ↗ ← All trials in China