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

Launched by GENEPLUS-BEIJING CO. LTD. · Jun 8, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new method to better classify pulmonary nodules—small growths in the lungs that could be cancerous—using advanced technology called whole-genome methylation sequencing (GM-seq). The goal is to improve the early detection of lung cancer, which is a significant health issue in China. By combining this new technology with traditional methods, researchers hope to determine if GM-seq can provide more accurate information about whether these nodules are benign (non-cancerous) or malignant (cancerous) before surgery.

To participate in this study, individuals must be between 20 and 75 years old and have a pulmonary nodule that is 1-3 cm in size, confirmed by a chest CT scan. The nodules should be suspected of being cancerous and should be suitable for surgical removal. Participants will undergo a bronchoscopy—a minimally invasive procedure to examine the lungs—and provide necessary clinical data. Throughout the trial, participants can expect regular visits to the hospital for assessments. It's important to note that patients who are unable to undergo this procedure or have certain other health conditions may not be eligible for the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female, 20-75 year-old with pulmonary nodules 1-3cm in diameter confirmed by chest CT;
• • 2. The nodules are single or multiple, suspected to be malignant, and have the indication 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 under bronchoscope;
• • 5. provide the collected clinical data needed by the research;
• • 6. Patients have the ability to follow the planned schedule and actively cooperate to return to the hospital for regular clinical visits.
• 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 advanced lung 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 serious diseases 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 the researcher to be unsuitable for participating in this study.