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

  • End date
    Jun 1, 2024
  • participants needed
  • sponsor
    Geneplus-Beijing Co. Ltd.
Updated on 30 June 2022
Accepts healthy volunteers


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, we 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.

Condition Pulmonary Nodule, Solitary, Whole-genome Methylation Sequencing
Treatment Whole-genome Methylation Sequencing(GM-seq)
Clinical Study IdentifierNCT05415670
SponsorGeneplus-Beijing Co. Ltd.
Last Modified on30 June 2022


Yes No Not Sure

Inclusion Criteria

Male or female, 20-75 year-old with pulmonary nodules 1-3cm in diameter confirmed by chest CT
The nodules are single or multiple, suspected to be malignant, and have the indication of surgical resection
Patient accept imaging evaluation without advanced lung tumors and metastases
The location of the nodule in the lung is within the reach of lung biopsy under bronchoscope
provide the collected clinical data needed by the research
Patients have the ability to follow the planned schedule and actively cooperate to return to the hospital for regular clinical visits

Exclusion Criteria

Unwilling to accept the invasive examination and treatment of this study
Contraindication of tracheoscopy
Consider that the pulmonary nodules are metastatic tumors or unresectable advanced lung cancer
Those who cannot tolerate resection of pulmonary nodules
Accompanied by other malignant tumors
In the judgment of the researcher, the patient also suffers from other serious diseases that may affect the accuracy of the test
Those who cannot accept the use of contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT)
Any other illness, social / psychological problems, etc. are judged by the researcher to be unsuitable for participating in this study
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