MedTrace Logo

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

NCT07370077 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1800

Last updated 2026-01-27

No results posted yet for this study

Summary

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

Interventions

DIAGNOSTIC_TEST

Employing multi-omics diagnostic approaches to enhance diagnostic efficacy

The study will first systematically evaluate the efficacy and accessibility of metabolomics and radiomics in the early screening and diagnosis of lung cancer through retrospective data analysis of prospective databases and prospective cohort validation. Based on large-scale detection data, a novel multidimensional early-stage lung cancer screening system will be established. This system will employ metabolomics as the initial screening method, supplemented by multi-omics approaches including radiomics, cfDNA methylation fragment detection, TCR detection, and metabolomics for differential diagnosis and confirmation.

Sponsors & Collaborators

  • Chen KeZhong

    lead OTHER

  • Tangshan Workers' Hospital

    collaborator UNKNOWN

  • School of Medical Science and Engineering, Beihang University

    collaborator UNKNOWN

  • China Aerospace Science and Industry Corporation No. 731 Hospital

    collaborator UNKNOWN

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER

  • Rongcheng County People's Hospital

    collaborator UNKNOWN

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07370077 on ClinicalTrials.gov