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Benign/Malignant Pulmonary Nodule Classification Based on High-throughput Whole-genome Methylation Sequencing(GM-seq)

NCT05415670 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 158

Last updated 2025-09-04

No results posted yet for this study

Summary

Lung cancer is the first cancer in China in terms of morbidity and mortality. The problem of early diagnosis/treatment has always been concerned. The popularization of chest CT (electronic computed tomography) screening makes it possible to detect lung cancer early. However, the diagnosis still needs pathological evidence. It is an ideal choice to obtain pathological evidence through bronchoscope and other minimally invasive means before surgical resection. However, the positive rate of tracheoscopy is still unsatisfactory, which is related to the difficulty of traditional pathological detection in detecting small specimens obtained by tracheoscopy. Liquid biopsy technology based on methylation detection has been used in early cancer screening, but its advantages have not been fully exploited due to the low content of ctDNA (circulating tumor DNA) in the current detection samples. Therefore, through prospective clinical research, the investigators plan to combine the methylation detection technology based on "Whole genome methylation sequencing(GM-seq)" with tracheoscopy, compare the traditional pathological methods with methylation detection on the bronchoscopic samples of lung nodule subjects suspected of early lung cancer, and take the postoperative pathology as the gold standard for judging benign and malignant, to confirm the feasibility and advantages of the new technology.

Conditions

  • Pulmonary Nodule, Solitary
  • Whole-genome Methylation Sequencing

Interventions

DIAGNOSTIC_TEST

Whole-genome Methylation Sequencing(GM-seq)

A Whole-genome Methylation detection method, which can analyze the genome-wide, single base resolution methylation of tissue / blood samples, and is used to develop a benign and malignant classification model for Pulmonary Nodule.

Sponsors & Collaborators

  • Beijing Hospital

    collaborator OTHER_GOV

  • Emergency General Hospital

    collaborator OTHER

  • Geneplus-Beijing Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Wei Zhou, Doctor · Beijing Hospital

  • Yunzhi Zhou, Doctor · Emergency General Hospital

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2025-06-01
Completion
2025-08-01

Countries

  • China

Study Locations

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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 NCT05415670 on ClinicalTrials.gov