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| Name | Class |
|---|---|
| Ann & Robert H Lurie Children's Hospital of Chicago | OTHER |
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The Sponsor hypothesize that Next-generation Sequencing (NGS) can identify fungal pathogens, is more accurate than other noninvasive options and can report fungal genomic load.
The Sponsor aims to describe the incidence of positivity for fungal specific pathogens on NGS analysis in a high-risk immunocompromised pediatric population.
Secondarily, the Sponsor will correlate results of the NGS analysis to other approved fungal tests if performed at the discretion of the treating provider (e.g. blood culture results, radiographic findings, biopsy results, bronchoalveolar lavage findings, galactomannan results or b-D-glucan (BG) results as evaluated via FDA-approved "Fungitell" assay). The Sponsor will use these other fungal tests, in addition to clinical criterion, to classify subjects as having possible, probable and proven IFD according to established criteria, and compare these categories against results from NGS analysis.
Lastly, to quantitatively evaluate follow-up test results to determine fungal DNA genomic load in subjects with positive results.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of positivity for fungal specific pathogens on NGS analysis | We aim to describe the incidence of positivity for fungal specific pathogens on NGS analysis in a high-risk immunocompromised pediatric population. | 7 months |
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Inclusion Criteria:
Exclusion Criteria:
-Those without concern for fungal infection or those currently being treated for a presumed or documented fungal infection will not be recruited for this study
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Pediatric patients treated at Ann & Robert H. Lurie Children's Hospital of Chicago on the hematology, oncology, neuro-oncology and stem cell transplant unit
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| Name | Affiliation | Role |
|---|---|---|
| Amy Armstrong, MD | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| D005334 | Fever |
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001832 | Body Temperature Changes |
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Plasma
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |