Status:
RECRUITING
New Method to Differentiate Benign and Malignant Pulmonary Nodules.
Lead Sponsor:
China-Japan Friendship Hospital
Conditions:
Pulmonary Nodules
Eligibility:
All Genders
18+ years
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 (...
Detailed Description
The aim of this clinical trial is to establish a new method for differentiating benign and malignant pulmonary nodules by the combination of metabolomics analysis and artificial intelligence (AI) anal...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 29 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06056999
Start Date
September 29 2023
End Date
July 1 2025
Last Update
December 18 2024
Active Locations (1)
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1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029