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
This trial does not accept healthy volunteersQualifiers
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 population
Patients with pulmonary nodule \<3cm who are admitted to China-Japan Friendship Hospital and are scheduled for puncture biopsy or surgery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 3 trial groupsGroup A: A. pure ground-glass nodule
Group B: B. part-solid nodule
Group C: C. solid nodule
Trial outcomes
Primary outcomes
1
Establish an model for differentiating lung nodules.
To establish a new method for differentiating benign and malignant pulmonary nodules by the combination of metabolomics analysis and artificial intelligence (AI) image analysis.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov