跳至主要内容
临床试验/NCT06192303
NCT06192303招募中不适用

Prospective Study on the Efficacy and Safety of Bronchoalveolar Lavage Combined With Pathogen Metagenomic Sequencing Technology in the Diagnosis of Immune Checkpoint Inhibitor Associated Pneumonia

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
104
试验地点
1
主要终点
Positive predictive value (PPV), negative predictive value (NPV) in suspected CIP patients

研究概览

简要总结

Immune checkpoint inhibitor associated pneumonia (CIP) is a common immune related adverse reaction, accounting for 35% of all deaths. However, due to the lack of typical clinical symptoms and imaging manifestations, CIP needs to be differentiated from other diseases such as pulmonary infections and lung cancer progression. Currently, there is a lack of diagnostic gold standards, which belongs to exclusive diagnosis. Empirical diagnosis and treatment in clinical practice can easily lead to the abuse of hormones and antibiotics, and even misdiagnosis and mistreatment, resulting in patient death. Therefore, early identification of CIP and pulmonary infection is the key to successful diagnosis and treatment. The CIP diagnosis and treatment guidelines recommend performing bronchoalveolar lavage as appropriate, but there is still a lack of large-scale prospective clinical studies. The beneficial pathogen metagenomic sequencing technology for the diagnosis of pulmonary infections has not been mentioned. Our research group conducted a prospective clinical study for the first time to evaluate the effectiveness and safety of bronchoalveolar lavage combined with pathogen metagenomic sequencing technology in diagnosing CIP, explore biomarkers for diagnosing CIP, in order to improve the early diagnosis rate and treatment efficiency of CIP, and reduce the abuse of antibiotics and hormones.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Voluntarily sign an informed consent form;
  • Age range from 18 to 75 years old, regardless of gender;
  • Immunosuppressive host;
  • Symptoms, signs, or imaging signs of pneumonia are visible, and empirical anti infection treatment is ineffective.

排除标准

  • 未提供

结局指标

主要结局

Positive predictive value (PPV), negative predictive value (NPV) in suspected CIP patients

时间窗: 2023.01-2026.01

Sensitivity, specificity in suspected CIP patients

时间窗: 2023.01-2026.01

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Prospective Study on the Efficacy and Safety of... | 临床试验