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New Method to Differentiate Benign and Malignant Pulmonary Nodules.

Recruitingn/aAges 18 Years - anyAllChina-Japan Friendship Hospital
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In 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.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 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 โ‰ฅ2 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 โ‰ฅ3.0ร—10\^9/L, platelets โ‰ฅ75ร—10\^9/L, hemoglobin โ‰ฅ90g/L, alanine aminotransferase and aspartate aminotransferase โ‰ค2.5 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; * โ‰ฅ2 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.
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What it tests

  • Not listed
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Where

1 site
China-Japan Friendship Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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