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Research on Early Screening and Diagnosis of Pulmonary Nodules Based on Novel Non-invasive Technologies.

Recruitingn/aAges 18 Years - anyAllChen KeZhong
NCT07370077 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a prospective observational study designed to address the clinical challenge posed by the high false-positive rate associated with CT imaging in early lung cancer screening. The primary objective is to develop a multi-omics technology for early lung cancer screening, leveraging \*\*exhaled breath metabolomics, plasma metabolomics, radiomics, and liquid biopsy. Based on large-sample detection data, the study aims to construct a \*\*multi-dimensional, sequential decision-making system\*\*. This system utilises the high accessibility of metabolomics for primary screening, combined with radiomics and ctDNA technologies for subsequent \*\*differentiation and definitive diagnosis. The research plans to prospectively enrol 300 patients with non-small cell lung cancer, along with corresponding subjects with benign nodules and healthy controls. By optimising the model using machine lear

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📋 Eligibility rules (as published)
Inclusion Criteria 1. Age \>18 years old. 2. Availability of both exhaled breath and peripheral blood samples, and raw CT image data; the collection time is within one month before biopsy or surgical resection, and the subject has not received any treatment in between. 3. Pulmonary nodular lesions identified by chest CT with a diameter \< 3 cm. 4. Pulmonary nodular lesions must be surgically resected and have complete, definitive pathological information regarding their benign or malignant nature. 5. No prior history of malignant tumors. 6. Has not received anti-tumor treatments such as radiotherapy, chemotherapy, or targeted therapy. 7. Signed informed consent. Exclusion Criteria 1. Missing clinical data or incomplete sample collection. 2. Presence or suspicion of active infection or other severe co-morbidities. 3. Abnormal liver or kidney function. 4. Indefinite or inconclusive postoperative pathological results.
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What it tests

  • Employing multi-omics diagnostic approaches to enhance diagnostic efficacy
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Where

1 site
Peking University People's Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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