Assessment of the Fungal Infection Incidence Across Canada for High Risk Participants With Hematological Disease (P07501)

Study Overview
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Brief Summary
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This will be a retrospective study that includes retrospective chart reviews at major institutions across Canada. The intent of the study is to generate both regional and national incidence data for non-Candida invasive fungal infections (IFI) in high risk participants. The study will include participants receiving stem cell transplant and high dose chemotherapy treatment for leukemia.

Official Title
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Temporal Realistic Assessment of the Fungal Infection Incidence Across Canada for High Risk Subjects With Hematological Disease (TRAFIC)

Conditions
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Mycoses, Leukemia

Intervention / Treatment
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* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be eligible for study inclusion, the participant must have: A hematological malignancy requiring high dose chemotherapy with or without bone marrow transplant Exclusion Criteria: The participant is not eligible for study inclusion if: Their IFI is not related to hematological malignancies.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants at high risk for IFI<br>Participants will be considered high risk if they are undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants are also considered to be at high risk for IFI if they have undergone allogeneic hematopoietic stem-cell transplantation. | Other: Standard Care<br>* Health-care interventions will be recorded; no additional procedures outside the standard of care will be required.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution | Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections. | 365 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With a Specific Fungal Pathogen at a Single Institution | Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of participants with a specific fungal pathogen. | 365 days | 
| Percentage of Participants With Invasive Fungal Infections in Canada | Data were to be extracted from participant hospital records from 5-9 centers across Canada starting from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections. | 365 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hematological malignancy, fungal infection, leukemia