Clinical trial · Observational
Prospective Multicenter Evaluation of the MycoGenie Kit for the Diagnosis of Invasive Aspergillosis
Prospective Multicenter Evaluation of the MycoGenie Kit for the Diagnosis of Invasive Aspergillosis in Hematological Patients
NCT03349931CI-TRIAL-00097632MYCOGENIEcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the performances of the real-time PCR ADEMTECH kit of DNA extraction and detection of Aspergillus fumigatus in serum samples in patients at high-risk for invasive aspergillosis (IA). DNA detection will be associated with detection of TR34/L98H mutations in cyp51A gene, which confer azole resistance.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Aspergillosis in Patients With Onco-haematological Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DNA extraction and detection of Aspergillus fumigatus in serum samples | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Hematological patients
- description
- Hematological patients at high risk for invasive aspergillosis
- interventionNames
- Diagnostic Test: DNA extraction and detection of Aspergillus fumigatus in serum samples
Primary outcomes (1)
- measure
- Performance of PCR for Aspergillosis diagnosis
- timeFrame
- 6 months
- description
- Determination of the performances (Sensitivity, specificity, PPV and NPV) of the kit
Secondary outcomes (1)
- measure
- Detection of azole resistance
- timeFrame
- 6 months
- description
- Detection of TR34 and L98H mutations in the A. fumigatus single-copy number gene cyp51A.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult Patients (≥ 18 years) hospitalized in onco hematologic unit or in hematopoietic stem cell transplantation (HSCT) unit 2. Patients with acute leukemia undergoing induction for AML, ALL, chimotherapy with neutopenia \>10 days or Patients undergoing allogeneic stem cell chemotherapy transplantation 3. Patients with biweekly screening for GM detection in serum Exclusion Criteria: 1. Patient \< 18 years-old (minor) 2. Informed consent not available 3. Patient without affiliation to French social insurance 4. Patient without biweekly screening for GM detection in serum
References
Publications (2)
- BACKGROUNDSuarez F, Lortholary O, Buland S, Rubio MT, Ghez D, Mahe V, Quesne G, Poiree S, Buzyn A, Varet B, Berche P, Bougnoux ME. Detection of circulating Aspergillus fumigatus DNA by real-time PCR assay of large serum volumes improves early diagnosis of invasive aspergillosis in high-risk adult patients under hematologic surveillance. J Clin Microbiol. 2008 Nov;46(11):3772-7. doi: 10.1128/JCM.01086-08. Epub 2008 Sep 24. PMID 18845828
- BACKGROUNDDannaoui E, Gabriel F, Gaboyard M, Lagardere G, Audebert L, Quesne G, Godichaud S, Verweij PE, Accoceberry I, Bougnoux ME. Molecular Diagnosis of Invasive Aspergillosis and Detection of Azole Resistance by a Newly Commercialized PCR Kit. J Clin Microbiol. 2017 Nov;55(11):3210-3218. doi: 10.1128/JCM.01032-17. Epub 2017 Aug 16. PMID 28814586