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

Last updated: July 16, 2024
Sponsor: Geneplus-Beijing Co. Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pulmonary Nodules

Treatment

Whole-genome Methylation Sequencing(GM-seq)

Clinical Study ID

NCT05415670
GM-Lung diagnosis
  • Ages 20-75
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female, 20-75 year-old with pulmonary nodules 1-3cm in diameter confirmed bychest CT;

  2. The nodules are single or multiple, suspected to be malignant, and have theindication of surgical resection;

  3. Patient accept imaging evaluation without advanced lung tumors and metastases;

  4. The location of the nodule in the lung is within the reach of lung biopsy underbronchoscope;

  5. provide the collected clinical data needed by the research;

  6. Patients have the ability to follow the planned schedule and actively cooperate toreturn to the hospital for regular clinical visits.

Exclusion

Exclusion criteria:

  1. Unwilling to accept the invasive examination and treatment of this study;

  2. Contraindication of tracheoscopy;

  3. Consider that the pulmonary nodules are metastatic tumors or unresectable advancedlung cancer;

  4. Those who cannot tolerate resection of pulmonary nodules;

  5. Accompanied by other malignant tumors;

  6. In the judgment of the researcher, the patient also suffers from other seriousdiseases that may affect the accuracy of the test;

  7. Those who cannot accept the use of contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT);

  8. Any other illness, social / psychological problems, etc. are judged by theresearcher to be unsuitable for participating in this study.

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Whole-genome Methylation Sequencing(GM-seq)
Phase:
Study Start date:
July 01, 2023
Estimated Completion Date:
June 01, 2025

Connect with a study center

  • Beijing hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

  • Emergency general hospital

    Beijing, Beijing 100028
    China

    Active - Recruiting

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