New Method to Differentiate Benign and Malignant Pulmonary Nodules.
Recruiting · NCT06056999 · Observational (researchers observe without assigning treatment) · Lead sponsor: China-Japan Friendship Hospital
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed.
- China-Japan Friendship Hospital - Beijing, Beijing Municipality, China