An observational study in Hematological Malignancies and Invasive Fungal Disease, sponsored by Nanfang Hospital, Southern Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Nanfang Hospital, Southern Medical University · Observational
Invasive fungal disease (IFD) refers to an infectious disease caused by fungi invading the human body, growing and reproducing in tissues, organs, or blood, and leading to inflammatory responses and tissue damage. Due to the suppression of immune system function during the disease and its treatment process, patients with hematological malignancies are prone to opportunistic infections, including IFD, with the lungs being the most common site of infection. In patients with hematological malignancies, IFD is often difficult to diagnose and progresses rapidly. Some patients become critically ill, which severely affects their prognosis. With the rapid development of molecular biology techniques, metagenomic next-generation sequencing (mNGS) of pathogenic microorganisms-as a broad-coverage, highly sensitive diagnostic tool with a short reporting cycle-has been widely applied in the etiological diagnosis of clinical infectious diseases. However, its clinical value in the diagnosis of IFD remains to be explored. This study is a single-center, single-arm, open-label clinical study to to explore the clinical performance of peripheral blood mNGS in the diagnosis and treatment of IFD in patients with hematological malignancies.
1,444 studies on the registry are indexed under Hematologic Neoplasms; 420 are open to participants now.
This study's planned enrollment of 50 is below the median of 186 across 322 observational studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Nanfang Hospital, Southern Medical University is the lead sponsor of 490 studies on the registry; 214 are open to participants now.
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The study population for this research consists of patients with hematological malignancies who are suspected of having IFD.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: metagenomic next-generation sequencing
The peripheral blood of the anticipants will be collected and sent to Tianjin Concord Bojing Medical Diagnostic Technology Co., Ltd. for mNGS testing.
The sensitivity and specificity of peripheral blood mNGS in diagnosing IFD
Time frame: up to 14 days
Start is estimated for Aug 2026; primary completion for Sep 2027, 13 months later.
Of 164 non-industry observational studies under Hematologic Neoplasms, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 322. This study's planned 13 months is below that.
Counting every sponsor, half of 186 studies reached it within 74 months; a quarter within 34 and three quarters within 322.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Nanfang Hospital, Southern Medical University →