Blood mNGS for Diagnosing Invasive Pulmonary Fungal Disease in Hematologic Patients (NCT07511595) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Blood mNGS for Diagnosing Invasive Pulmonary Fungal Disease in Hematologic Patients
1,000 participantsStarted 2026-04
Plain-language 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. 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
Who can participate
Age range
14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic power of metagenomic next-generation sequencing (mNGS) for invasive pulmonary fungal infections in hematological patients
. Voluntary signing of the informed consent form (or by the legal representative).
Exclusion criteria
. 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.