ImPACt on Invasive Fungal Infections by Immune Checkpoint Inhibition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Measurement of immune checkpoint expression levels in blood samples from patients with IFI and healthy controls by flowcytometry
研究概览
简要总结
This observational study aims to compare immune checkpoint expression in blood samples from patients with invasive fungal infections (IFI) against healthy controls.
详细描述
Participating sites will screen patients with invasive aspergillosis for eligibility. The investigators will enroll patients with aspergillosis and healthy controls. Patients will be informed by study personnel. Samples for imune phenotyping will be obtained within 7 days after diagnosis of IFI. A bronchoalveolar lavage (BAL) biopsy is taken at initial diagnostic bronchoscopy or other biopsy during surgical debridement whenever applicable and feasible.
The following data items will be collected: Patient characteristics, details on invasive fungal infection (IFI), underlying disease, outcome after 90 days (response, remission, progress, death). All collected data will be interpreted at the end of the study. All patients must agree to participate and sign the informed consent form.
The primary objective is to compare immune checkpoint expression in blood samples from patients with IFI against healthy controls. Exploratively, lymphocytic immune phenotypes in BAL or other biopsy samples from patients with IFI will be assessed. Further, cytotoxic T cell responses in blood samples from patients with IFI shall be investigated and the level of immune checkpoint expression correlated with mortality.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Proven or probable, incl. PCR, positive IFI along 2019 EORTC/MSG criteria
- •Signed ICF
排除标准
- 未提供
结局指标
主要结局
Measurement of immune checkpoint expression levels in blood samples from patients with IFI and healthy controls by flowcytometry
时间窗: 3 years
To compare immune checkpoint expression in blood samples from patients with IFI against healthy controls.
次要结局
- Determination of lymphocytic immune phenotypes in BAL and other biopsy samples by flowcytometry(3 years)
- Measurement of cytotoxic T cell responses in blood samples from patients with IFI by ELISA(3 years)
- Correlation of survival at day 30 and 90 and immune checkpoint expression levels(4 years)
研究者
Sibylle C Mellinghoff
Resident physician and research affiliate
University of Cologne