Non-invasive Diagnosis of Invasive Pulmonary Aspergillosis by Use of Biomarkers in Exhaled Breath Condensate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Identification of Aspergillus proteins in the EBC from patients with proven/probable/possible PA
研究概览
简要总结
In this study, a new, non-invasive method for diagnosis of pulmonary aspergillosis (PA) will be tested in a clinical pilot project.
详细描述
Background:
The search for biomarkers to enhance and improve diagnosis of PA is ongoing, mainly focused on markers detected in the blood and bronchoalveolar lavage (BAL) fluids. In this study, the investigators will investigate whether exhaled breath condensate is a useful source for diagnosis of PA either by existing methods (i.e. polymerase chain reaction (PCR) detection of Aspergillus DNA) or by analysis of the proteome. However, extraction of Aspergillus DNA has never been done in the EBC before. In this pilot study the investigators will investigate whether it is possible to purify DNA from pneumocystis from EBC of patients with proven pneumocystis pneumonia both because the diagnostic test for pneumocystis pneumonia is more sensitive and specific and also due to the fact that pneumocystis pneumonia is more common than PA. The investigators will spare the EBC samples from patients PA for the protein analysis in this study.
No previous studies have investigated the potential of EBC protein analysis as a diagnostic tool in PA infections. In this pilot study, the investigators will test whether Aspergillus proteins are present in the EBC from patients with proven/probable/possible PA.
Methods:
The study will compare the protein profiles of exhaled breath condensate (EBC) collected from patients with proven, probable or possible pulmonary aspergillus (PA) infection and patients with suspected PA infection where routine diagnostic workup ruled out PA, and negative controls, i.e. patients who undergo diagnostic workup for benign/indolent conditions and without suspected PA, with same age (within a range of 10 years) and gender from the outpatient clinic at department of hematology, department of infectious diseases, department of respiratory diseases and department of cardiothoracic surgery at Aalborg University Hospital. The main-outcome, i.e. means of the relative amounts of specific proteins in the EBC samples, will be compared by unpaired t-tests after assessment of normality and standard deviations within the two groups in the following comparisons: proven/probable/possible PA vs. patients where PA was ruled out and proven/probable/possible PA vs. negative controls. In case three groups are compared, the one-way analysis of variance will be applied, but this is not within the main scope of our study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Suspected/confirmed PA patients:
- •Hospitalized or ambulatory patients with a suspected PA at Aalborg University Hospital.
- •Are conscious and able to understand the given study information.
- •Possess legal capacity.
- •Age above 18 years.
- •Informed, signed consent is obtained.
- •Clinically stable, which is defined as patients with stable blood pressure and not in need for other treatments.
- •No need for organ support, which comprises need for vasopressors or inotropes, mechanical ventilation, extra corporal circulation or renal replacement therapy.
- •Patients as the PA patients, but where the diagnosis of PA is rejected will be included as controls.
- •Suspected/confirmed pneumocystis pneumonia patients:
- •Hospitalized or ambulatory patients with a suspected pneumocystis pneumonia at Aalborg University Hospital - chest x-ray must support the tentative diagnosis of pneumocystis pneumonia.
- •Are conscious and able to understand the given study information.
- •Possess legal capacity.
- •Age above 18 years.
- •Informed, signed consent is obtained.
- •Clinically stable, which is defined as patients with stable blood pressure and not in need for other treatments.
- •No need for organ support, which comprises need for vasopressors or inotropes, mechanical ventilation, extra corporal circulation or renal replacement therapy.
- •Patients as the pneumocystis pneumonia patients, but where the diagnosis is rejected.
- •Healthy controls for the confirmed PA patients and confirmed pneumocystis pneumonia patients In addition, 19 healthy controls (i.e. patients/subjects who undergo diagnostic work-up for benign or indolent hematological diseases without suspected PA or pneumocystis pneumonia) will be recruited, as described below.
- •Healthy controls and patients who are going through diagnostic work-up for indolent hematological cancer types or benign hematological diseases, at the Department of Hematology, Aalborg University Hospital.
- •Same gender and age (within a 10-year range) as an included patient with proven/probable/possible PA (15 subjects).
- •Same gender and age (within a 10-year range) as an included patient with verified pneumocystis pneumonia (4 subjects).
- •Are conscious and able to understand the given study information.
- •Possess legal capacity.
- •Age above 18 years.
- •Informed, signed consent is obtained.
排除标准
- •PA patients, pneumocystis pneumonia patients and controls:
- •No upper age limit will be applied.
结局指标
主要结局
Identification of Aspergillus proteins in the EBC from patients with proven/probable/possible PA
时间窗: 2-3 years
The primary outcome is identification of Aspergillus proteins in the EBC from patients with proven/probable/possible PA
次要结局
- Detection of Pneumocystis DNA in the EBC(1-2 years)
研究者
Inger Lise Gade
Principal Investigator, Registrar, MD, PhD
Aalborg University Hospital