Prospective Multicenter Clinical Study of Blood Microbial Metagenomic Next-Generation Sequencing (mNGS) for the Diagnosis of Invasive Pulmonary Fungal Disease in Patients With Hematologic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- Diagnostic power of metagenomic next-generation sequencing (mNGS) for invasive pulmonary fungal infections in hematological patients
研究概览
简要总结
The goal of this clinical trial is to learn whether a blood test called metagenomic next-generation sequencing (mNGS) can help diagnose invasive pulmonary fungal disease in patients with blood disorders. It will also evaluate how accurate this test is compared to traditional methods. The main questions it aims to answer are:
Can blood mNGS accurately identify the fungi causing lung infections?
How well does blood mNGS perform compared to conventional tests (such as culture, serum markers, and imaging)?
Does the mNGS result influence doctors' decisions to start, change, or stop antifungal treatment?
This study is a multicenter, prospective, observational trial. Researchers will compare the mNGS test with standard diagnostic methods to assess its usefulness in early diagnosis of fungal lung infections.
Participants will:
Have a blood sample collected within 72 hours of enrollment for mNGS testing
Undergo routine clinical tests, including imaging, serum markers, and cultures, as part of standard care
Be followed for 42 days to collect information on treatment and clinical outcomes
详细描述
What is this study about?
This study focuses on patients with blood disorders (such as leukemia, lymphoma, or multiple myeloma) or those who have received a stem cell transplant. These patients are at high risk for developing a serious lung infection caused by fungi, known as invasive pulmonary fungal disease. This infection can be life-threatening if not treated quickly, but it is often difficult to diagnose in its early stages.
Currently, doctors use several methods to look for fungal infections, including CT scans, blood tests for fungal markers, and cultures from lung samples. However, these tests can be slow, sometimes miss the infection, or may not clearly distinguish between infection and other lung problems. In some cases, obtaining a lung sample requires an invasive procedure called bronchoscopy, which can be uncomfortable and carries risks.
What is the new test being studied?
This study is evaluating a new type of blood test called metagenomic next-generation sequencing, or mNGS for short. Unlike traditional tests that look for one specific fungus at a time, mNGS scans the blood for DNA fragments from hundreds of different fungi, bacteria, and other microbes all at once. It works like a powerful search tool that can quickly identify the cause of an infection from a simple blood sample.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥14 years, gender unrestricted.
- •Patients diagnosed with hematologic malignancies (leukemia, lymphoma, myeloma, etc.) or those who have undergone autologous/allogeneic HSCT.
- •Chest CT confirmed the presence of pulmonary lesions.
- •Clinical suspicion of IFD (with symptoms such as fever, cough, and dyspnea).
- •No other etiological evidence (blood culture, respiratory specimen PCR, etc.) was found.
- •At least one high-risk factor for IFD is present: agranulocytosis (absolute neutrophil count <0.5×10⁹/L), long-term (≥2 weeks) use of glucocorticoids (prednisone equivalent dose ≥0.5 mg/kg/day), concurrent severe acute graft-versus-host disease (GVHD) or moderate-to-severe chronic graft-versus-host disease (cGVHD), cytomegalovirus (CMV) infection or activation, or treatment with T-cell immunosuppressants.
- •Voluntary signing of the informed consent form (or by the legal representative).
排除标准
- •Clinicians determine that the pulmonary lesion is not caused by IFD (e.g., bacterial pneumonia, tumor infiltration, etc.).
- •The patient or his legal representative withdraws the informed consent.
- •Due to severe underlying diseases, mental disorders, etc., the individual has lost the capacity for autonomous signing and lacks a suitable legal representative.
研究组 & 干预措施
Study Cohort
All eligible patients with hematologic diseases suspected of having invasive pulmonary fungal disease will be enrolled in this single cohort.
干预措施: Blood microbial metagenomic next-generation sequencing (mNGS) (Other)
结局指标
主要结局
Diagnostic power of metagenomic next-generation sequencing (mNGS) for invasive pulmonary fungal infections in hematological patients
时间窗: 42days from enrollment
The diagnostic performance of blood metagenomic next-generation sequencing (mNGS) for invasive pulmonary fungal disease (IFD), assessed by: Sensitivity Specificity Positive predictive value (PPV) Negative predictive value (NPV) Accuracy All diagnostic parameters will be evaluated at 42 days after enrollment, using the EORTC/MSG 2020 consensus definitions for IFD (proven, probable, possible, or no IFD) as the reference standard.
次要结局
未报告次要终点
研究者
Xiao-Jun Huang
Professor
Peking University People's Hospital