Invasive Pulmonary Fungal DiseaseNCT07511595
Blood mNGS for Diagnosing Invasive Pulmonary Fungal Disease in Hematologic Patients
An observational study of Invasive Pulmonary Fungal Disease, run by Peking University People's Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Invasive Pulmonary Fungal Disease
- What is being tested?
- Blood microbial metagenomic next-generation sequencing (mNGS)
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is a prospective, multicenter diagnostic study enrolling patients (≥14 years) with underlying hematologic diseases who are clinically suspected of having invasive pulmonary fungal disease.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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?
Read more
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
Read the detailed description
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.
Why is this study being done?
The main goal is to find out whether this blood test can accurately diagnose fungal lung infections in high-risk patients. Researchers want to know:
How well does the mNGS test detect fungal infections compared to current standard tests?
Can the test results help doctors start the right antifungal treatment sooner?
Could this blood test reduce the need for more invasive procedures like bronchoscopy?
Who can take part?
The study will enroll patients who:
Have a blood disorder or have received a stem cell transplant
Have a new lung abnormality seen on a CT scan
Are suspected of having a fungal lung infection
Have at least one risk factor for fungal infection, such as a weakened immune system
Participants will be recruited from multiple hospitals across the country.
What happens if someone joins the study?
Participation in the study involves:
A blood sample taken within 72 hours of joining. This sample will be sent to a central lab for mNGS testing. The cost of this first test is covered by the study.
Routine medical care as determined by their own doctor, which may include standard tests such as blood cultures, fungal marker tests, and imaging. If a bronchoscopy is already planned as part of routine care, the fluid from the lungs will also be tested with mNGS at no additional cost.
Follow-up for 42 days. During this time, the research team will collect information about the patient's symptoms, treatments, and test results. No extra visits are required beyond what is already part of standard care.
The mNGS results will not be shared with the treating doctors during the study period, so they will not influence routine care. This allows researchers to fairly compare the new test against standard methods.
What are the potential benefits?
If the study shows that blood mNGS is accurate, it could offer a faster, less invasive way to diagnose fungal lung infections. Early diagnosis may lead to earlier treatment, which could improve outcomes for patients. The study may also help establish clear guidelines for how and when to use this technology in the future.
Are there any risks?
The main risk is that the mNGS test may give results that are not fully accurate, but since these results are not used to guide patient care during the study, there is no direct risk from the test itself. The blood draw involves typical minor discomfort and bruising. All personal health information will be kept confidential.
Who is organizing this study?
The study is led by researchers at Peking University People's Hospital in collaboration with several major medical centers across China. It is supported by a diagnostic laboratory that will perform the mNGS testing.
How long will the study last?
Patient enrollment is expected to take 18 to 24 months, and each participant will be followed for 42 days.
What happens after the study?
The results will help determine whether blood mNGS should become a standard tool for diagnosing fungal lung infections in high-risk patients. If successful, this approach may change clinical practice by enabling earlier, less invasive diagnosis and more targeted treatment.
- Conditions
- Invasive Pulmonary Fungal Disease
- Being tested
- Blood microbial metagenomic next-generation sequencing (mNGS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood microbial metagenomic next-generation sequencing (mNGS)Other
Blood samples will be collected and analyzed using microbial metagenomic next-generation sequencing (mNGS) technology for the detection of invasive pulmonary fungal pathogens.
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | All eligible patients with hematologic diseases suspected of having invasive pulmonary fungal disease will be enrolled in this single cohort. Receives: Other: Blood microbial metagenomic next-generation sequencing (mNGS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic power of metagenomic next-generation sequencing (mNGS) for invasive pulmonary fungal infections in hematological patients
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.
Measured: 42days from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Pulmonary Fungal DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Hebei Yanda Ludaopei Hospital, Chinese PLA General Hospital, The First Affiliated Hospital of Zhengzhou University, Shandong Provincial Hospital, Qilu Hospital of Shandong University, First Affiliated Hospital of Zhejiang University, KingMed Diagnostics
- Responsible party
- Principal investigator, Xiao-Jun Huang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511595
- Sponsor's protocol ID
- PKUPH20260120
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07511595
- Acronym / sponsor ID
- PKUPH20260120
- Conditions
- Invasive Pulmonary Fungal Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Hebei Yanda Ludaopei Hospital, Chinese PLA General Hospital, The First Affiliated Hospital of Zhengzhou University, Shandong Provincial Hospital, Qilu Hospital of Shandong University, First Affiliated Hospital of Zhejiang University, KingMed Diagnostics
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Why is this study being done?
The main goal is to find out whether this blood test can accurately diagnose fungal lung infections in high-risk patients. Researchers want to know:
How well does the mNGS test detect fungal infections compared to current standard tests?
Can the test results help doctors start the right antifungal treatment sooner?
Could this blood test reduce the need for more invasive procedures like bronchoscopy?
Who can take part?
The study will enroll patients who:
Have a blood disorder or have received a stem cell transplant
Have a new lung abnormality seen on a CT scan
Are suspected of having a fungal lung infection
Have at least one risk factor for fungal infection, such as a weakened immune system
Participants will be recruited from multiple hospitals across the country.
What happens if someone joins the study?
Participation in the study involves:
A blood sample taken within 72 hours of joining. This sample will be sent to a central lab for mNGS testing. The cost of this first test is covered by the study.
Routine medical care as determined by their own doctor, which may include standard tests such as blood cultures, fungal marker tests, and imaging. If a bronchoscopy is already planned as part of routine care, the fluid from the lungs will also be tested with mNGS at no additional cost.
Follow-up for 42 days. During this time, the research team will collect information about the patient's symptoms, treatments, and test results. No extra visits are required beyond what is already part of standard care.
The mNGS results will not be shared with the treating doctors during the study period, so they will not influence routine care. This allows researchers to fairly compare the new test against standard methods.
What are the potential benefits?
If the study shows that blood mNGS is accurate, it could offer a faster, less invasive way to diagnose fungal lung infections. Early diagnosis may lead to earlier treatment, which could improve outcomes for patients. The study may also help establish clear guidelines for how and when to use this technology in the future.
Are there any risks?
The main risk is that the mNGS test may give results that are not fully accurate, but since these results are not used to guide patient care during the study, there is no direct risk from the test itself. The blood draw involves typical minor discomfort and bruising. All personal health information will be kept confidential.
Who is organizing this study?
The study is led by researchers at Peking University People's Hospital in collaboration with several major medical centers across China. It is supported by a diagnostic laboratory that will perform the mNGS testing.
How long will the study last?
Patient enrollment is expected to take 18 to 24 months, and each participant will be followed for 42 days.
What happens after the study?
The results will help determine whether blood mNGS should become a standard tool for diagnosing fungal lung infections in high-risk patients. If successful, this approach may change clinical practice by enabling earlier, less invasive diagnosis and more targeted treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Other: Blood microbial metagenomic next-generation sequencing (mNGS)All eligible patients with hematologic diseases suspected of having invasive pulmonary fungal disease will be enrolled in this single cohort. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a prospective, multicenter diagnostic study enrolling patients (≥14 years) with underlying hematologic diseases who are clinically suspected of having invasive pulmonary fungal disease.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood microbial metagenomic next-generation sequencing (mNGS)Blood samples will be collected and analyzed using microbial metagenomic next-generation sequencing (mNGS) technology for the detection of invasive pulmonary fungal pathogens. | Other | Study Cohort |
Primary outcome
Diagnostic power of metagenomic next-generation sequencing (mNGS) for invasive pulmonary fungal infections in hematological patients
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Pulmonary Fungal Disease, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact RUI MA (8613041076278, marui_pku_ed@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic power of metagenomic next-generation sequencing (mNGS) for invasive pulmonary fungal infections in hematological patients (time frame: 42days from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.