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Report for Clinical Trial NCT03349931

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Prospective Multicenter Evaluation of the MycoGenie Kit for the Diagnosis of Invasive Aspergillosis in Hematological Patients

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.

NCT03349931 Invasive Aspergillosis in Patients With Onco-haematological Diseases
MeSH: Aspergillosis

1 Interventions

Name: DNA extraction and detection of Aspergillus fumigatus in serum samples

Description: Performances diagnostic test 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).

Type: Diagnostic Test

Hematological patients


Primary Outcomes

Description: Determination of the performances (Sensitivity, specificity, PPV and NPV) of the kit

Measure: Performance of PCR for Aspergillosis diagnosis

Time: 6 months

Secondary Outcomes

Description: Detection of TR34 and L98H mutations in the A. fumigatus single-copy number gene cyp51A.

Measure: Detection of azole resistance

Time: 6 months

Time Perspective: Prospective

Cohort


There is one SNP

SNPs


1 L98H

DNA detection will be associated with detection of TR34/L98H mutations in cyp51A gene, which confer azole resistance. --- L98H ---

Detection of TR34 and L98H mutations in the A. fumigatus single-copy number gene cyp51A.. 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 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 Invasive Aspergillosis in Patients With Onco-haematological Diseases Aspergillosis Accurate diagnosis of invasive pulmonary aspergillosis (IPA) in patients at high risk of invasive fungal infection remains challenging due to difficulties in differentiating IPA from pulmonary infections caused by other molds or bacteria on clinical and radiological grounds. --- L98H ---

Azole resistance in A. fumigatus is associated mainly with mutations in the cyp51A gene, and among several mutations described, the most frequent is the mutation comprising a 34-bp tandem repeat (TR34) and the L98H alteration. --- L98H ---

This multiplex assay detects DNA from the A. fumigatus species complex by targeting the multicopy 28S rRNA gene and specific TR34 and L98H mutations in the single-copy number cyp51A gene of A. fumigatus. --- L98H ---



HPO Nodes