๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Age โฅ18 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 โฅ2 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 โฅ3.0ร10\^9/L, platelets โฅ75ร10\^9/L, hemoglobin โฅ90g/L, alanine aminotransferase and aspartate aminotransferase โค2.5 times the upper limit of normal values, and serum creatinine \<178ฮผmol/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;
* โฅ2 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.