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临床试验/NCT05415670
NCT05415670已完成不适用

Development a Pulmonary Nodules Diagnosis Classification Model for Benign/Malignant of Bronchoscopic Biopsy Specimens Based on High-throughput Whole-genome Methylation Sequencing(GM-seq)

Geneplus-Beijing Co. Ltd.2 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
158
试验地点
2
主要终点
Area under the receiver operating characteristic curve (ROC)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

Area under the receiver operating characteristic curve (ROC)

时间窗: 2 years

Area under curve (AUC) of GM-seq data in discriminating malignant nodules from benign nodules.

次要结局

未报告次要终点

研究者

发起方
Geneplus-Beijing Co. Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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