| DB ID | MyCo_5990 |
| Title | Prospective Evaluation of Galactomannan and (1→3) β-d-Glucan Assays as Diagnostic Tools for Invasive Fungal Disease in Children, Adolescents, and Young Adults With Acute Myeloid Leukemia Receiving Fungal Prophylaxis |
| Year | 2021 |
| PMID | 34173659 |
| Fungal Diseases involved | Invasive fungal infection |
| Associated Medical Condition | Acute Myeloid Leukemia |
| Genus | None |
| Species | None |
| Organism | None |
| Ethical Statement | This study was approved by the National Cancer Institute’s Central Institutional Review Board (IRB) and IRBs at each participating institution. |
| Site of Infection | None |
| Opportunistic invasive | None |
| Sample type | Body fluid |
| Sample source | Blood |
| Host Group | Human |
| Host Common name | Human |
| Host Scientific name | Homo sapiens |
| Biomarker Name | GM |
| Biomarker Full Name | Galactomannan |
| Biomarker Type | Negative |
| Biomolecule | Protein |
| Geographical Location | USA |
| Cohort | This was a prospective observational study imbedded within a randomized controlled open-label phase III Children’s Oncology Group trial (ACCL0933) comparing caspofungin prophylaxis versus fluconazole prophylaxis during neutropenic periods in children, adolescents and young adults with AML. Participants were eligible for the randomized trial if they had newly diagnosed de novo, relapsed or secondary AML, or had planned treatment with standard AML chemotherapy for other diagnoses (eg, mixed phenotype acute leukemia) and were between 3 months and 30 years of age. Among 471 patients enrolled, 425 participants (209 fluconazole and 216 caspofungin) contributed ≥1 blood specimen. In total, 6103 specimens were evaluated. |
| Cohort No. | 471 |
| Age Group | 3 Months - 30 years |
| P Value | None |
| Sensitivity | 0 |
| Specificity | None |
| Positive Predictive Value | 0 |
| MIC | None |
| Fold Change | None |
| Pathway | None |
| Disease Introduction Mechanism | Current chemotherapy protocols for acute myeloid leukemia (AML) result in repeated periods of profound and prolonged neutropenia. During these neutropenic periods, patients are at high risk for invasive fungal disease (IFD), particularly invasive candidiasis (IC) and invasive aspergillosis (IA), which are associated with substantial morbidity and mortality. Early diagnosis leading to more rapid initiation of targeted antifungal therapy can improve outcomes. |
| Technique | Immunological assay |
| Analysis Method | Platelia Aspergillus galactomannan (GM) enzyme immunoassay (EIA) |
| ELISA kits | None |
| Assay Data | FDA- Platelia Aspergillus galactomannan (GM) enzyme immunoassay (EIA), Fungitell β-d-glucan (BDG) assay |
| Validation Techniques used | Platelia Aspergillus galactomannan (GM) enzyme immunoassay (EIA) |
| Up Regulation Down Regulation | None |
| Sequence Data | None |
| External Link | None |
