Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT07370077

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

Led by Chen KeZhong · Updated on 2026-01-27

1800

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

Sponsors

C

Chen KeZhong

Lead Sponsor

T

Tangshan Worker's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years old
  • Availability of exhaled breath and peripheral blood samples and raw CT image data collected within one month before biopsy or surgery without any treatment in between
  • Pulmonary nodular lesions detected by chest CT with diameter less than 3 cm
  • Pulmonary nodules must be surgically removed with complete and definitive pathology confirming benign or malignant status
  • No prior history of malignant tumors
  • No prior anti-tumor treatments such as radiotherapy, chemotherapy, or targeted therapy
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Missing clinical data or incomplete sample collection
  • Presence or suspicion of active infection or other severe co-morbid conditions
  • Abnormal liver or kidney function
  • Unclear or inconclusive postoperative pathological results

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking University People's Hospital

Beijing, Beijing Municipality, China, 10010

Actively Recruiting

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Research Team

F

Fan Yang, Chief Physician

CONTACT

Z

zhong Ke Chen

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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