NCT07370077Recruiting
Research on Early Screening and Diagnosis of Pulmonary Nodules Based on Novel Non-invasive Technologies.
Research on Precise Early Screening and Diagnosis of Pulmonary Nodules Based on a Novel Multidimensional Non-invasive Approach
Source: ClinicalTrials.gov · Last updated 27 Jan 2026
Brief summary (registry, in English)
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 learning and deep learning algorithms (such as SVM, HRNet, and PAResNet), the ultimate goal is to establish a novel lung cancer early screening system characterised by \*\*high sensitivity, high accuracy, and high accessibility\*\*, enabling the precise differentiation and screening of healthy individuals, benign pulmonary nodules, and early-stage lung cancer.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1800 (estimated)
- First submitted
- 19 Jan 2026
- Start date
- 31 Dec 2022
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Chen KeZhong
- Diseases
- Lung cancer
- NCT number
- NCT07370077
What you commit to
- Study type: Observational
- Planned participants: 1800
- From 31 Dec 2022 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence or suspicion of active infection or other severe co-morbidities.
Other
- Missing clinical data or incomplete sample collection.
- Abnormal liver or kidney function.
- Indefinite or inconclusive postoperative pathological results.
Who the study is looking for
- Age \>18 years old.
- 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.
- Pulmonary nodular lesions identified by chest CT with a diameter \< 3 cm.
- Pulmonary nodular lesions must be surgically resected and have complete, definitive pathological information regarding their benign or malignant nature.
- No prior history of malignant tumors.
- Has not received anti-tumor treatments such as radiotherapy, chemotherapy, or targeted therapy.
- Signed informed consent.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.