New Method to Differentiate Benign and Malignant Pulmonary Nodules.
ConditionPulmonary Nodules
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChina-Japan Friendship Hospital
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Not listed
Trial groups
150 Participants
are grouped into 3 trial groupsSponsors and collaborators
Source ClinicalTrials.gov