Early screening and diagnosis of lung nodules using non-invasive biomarkers and imaging.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational effort enrolling patients with pulmonary nodules who undergo surgical resection and definitive pathology, along with matched benign-nodule subjects and healthy controls. The protocol collects exhaled breath and plasma metabolomics, CT radiomics, and liquid biopsy (ctDNA) samples within one month before biopsy or surgery. Large-sample multi-omics data will be integrated using machine learning and deep learning models (for example SVM, HRNet, PAResNet) to build a multi-dimensional, sequential decision system that uses metabolomics for primary screening and radiomics/ctDNA for subsequent differentiation and diagnosis. The goal is to reduce false positives from CT screening and provide a non- or minimally-invasive pathway to more accurate early diagnosis.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Fan Yang, Chief Physician
• Email: yangfan@pkuph.edu.cn
• Phone: 0086-88326657

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.