Blood biomarkers to help diagnose invasive mucormycosis
Official title: Diagnostic Marker of Mucormycosis : Development and Evaluation of a Diagnostic Assay on a Cohort of Sera
Run by University Hospital, Lille · NCT05406037 · Data updated 2026-11-12
This project will test a blood biomarker that looks for unique fungal sugars to see if it can detect invasive mucormycosis in patients with suspected infection, compared with high-risk patients without infection and patients with other fungal infections.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 3 Years to 64 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille, Hauts-de-France) |
| Status | Recruiting |
| Started | November 29, 2023 |
| Main results expected | July 2026 |
| Study ends | July 2026 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT05406037 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are patients aged 3–64 with confirmed invasive mucormycosis treated at the University Hospital of Lille, plus control groups of high-risk pre-transplant patients (18–64) without infection and patients with other invasive fungal infections.
✕Probably not a fit
People unlikely to benefit include asymptomatic individuals, patients outside the enrolled age ranges, or those with infections not caused by Mucorales.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational, hospital-based cohort study using venous blood samples to search for uncommon monosaccharides and oligo/polysaccharides from Mucorales cell walls as potential diagnostic markers. The study enrolls confirmed mucormycosis cases and two control groups: high-risk patients without active infection (pre-transplant assessment) and patients with other invasive fungal infections. Samples will be analyzed in specialized laboratories using biochemical and molecular methods and results compared across groups to determine marker specificity and timing. The goal is to identify whether these cell-wall-derived markers appear reliably in blood early enough to aid clinical decision-making.
Why it matters
Potential benefit: If successful, the test could enable earlier and more specific diagnosis of mucormycosis, allowing faster targeted antifungal treatment and potentially lowering mortality.
How similar studies have gone: Biomarker tests like galactomannan or beta-D-glucan are used for other fungal infections, but targeting unique Mucorales cell-wall sugars is relatively novel and not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Men and women
* Age : Children and adults from 3 to 64 years old (18 to 64 for controls)
* In patients whose consent has been collected after information. In the case of children, information on the study will be given to the holders of parental authority and then to the child to obtain their consent.
* Patient social insured
* Specific medical conditions :
1. For the case group :
Any patient hospitalized in one of the departments of the University Hospital of Lille, in which the diagnosis of mucormycosis was conducted on the following criteria:
* Conventional mycology data and / or
* Positivity of q-PRC and / or
* Anatomopathologic diagnosis Associated with a compatible clinical situation
2. For the control group 1 Patient assessed for hematopoietic stem cell transplantation, considered at risk for IFI but for whom the pre-transplantation review will have excluded an ongoing infection
3. For control group 2 Any patient hospitalized in a department of Lille University Hospital, in which the diagnosis of disseminated candidiasis or invasive pulmonary aspergillosis has been made according to specific classifications (EORTC/MSG criteria, AspICU criteria)
Exclusion Criteria:
* Patients for whom the inclusion criteria are not met
* Co-infection mucormycosis/other IFI
Where it's running
-
University Hospital of Lille
Lille, Hauts-de-France, France Recruiting
Study contacts
- Principal investigator: Marjorie CORNU, MD — University Hospital, Lille
- Study coordinator: Marjorie CORNU, MD
- Email: marjorie.cornu@chru-lille.fr
- Phone: 0320445962
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.