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NCT05774990 Clinical Trial

Study Protocol: Study on Incidence and Risk Factors of Mold Infections in Children During Leukemia Treatment

Acute Lymphoblastic Leukemia Clinical Trial

Official title:
Incidence and Risk Factors for Invasive Mold Infections in Children During First-Line Chemotherapy for Primary Acute Leukemia: Protocol for a National Retrospective Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05774990
Other study ID # 22/15850
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date August 2025

Study information
Verified date May 2024
Source University of Southern Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study aims to evaluate the occurrence, mortality, and risk factors for invasive mold infections (IMI) in children treated with chemotherapy for acute leukemia in Denmark. The study will be a retrospective nationwide survey study of all children who received first-line chemotherapy for acute leukemia from 2008 to 2022 in Danish pediatric oncology units. The study population will include approximately 800 children under the age of 18. Data will be collected from medical records, hospital databases, and national databases. When the IMI subgroup has been identified, this will be compared to the leukemic group that did not develop IMI. Statistical analysis can then determine the occurrence, mortality rate, and possible IMI risk factors.

Description:

Chemotherapy can weaken children's immune system, making them vulnerable to infections, including invasive mold infections (IMI), caused mainly by Aspergillus spp. The at-risk population for IMI in children with acquired immunodeficiency is patients with prolonged granulocytopenia due to hematologic malignancies treated with chemotherapy or allogeneic hematopoietic stem cell transplantation (HSCT) recipients and children receiving long-term corticosteroid treatment. Incidences and mortality rates are often reported as high. In a retrospective cohort study, we aim to obtain an epidemiological overview of IMI in children receiving first-line treatment for acute myelogenous leukemia (AML) and acute lymphoblastic leukemia (ALL) in Denmark from 2008 to 2022 and identify possible risk factors, including treatment-related adverse effects. Objectives 1. To determine and compare the incidence of IMI in childhood AML and ALL during first-line chemotherapy in Denmark. 2. To determine and compare the mortality of IMI in childhood AML and ALL during first-line chemotherapy in Denmark. 3. To explore risk factors for IMI in childhood AML and ALL during first-line chemotherapy in Denmark.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 800
Est. completion date August 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group N/A to 17 Years
Eligibility Inclusion Criteria: - Age <18 years at the time of inclusion - Received first-line treatment for ALL or AML - Treatment at a Danish tertiary pediatric oncology unit (Rigshospitalet, Aarhus University Hospital, Odense University Hospital, and Aalborg University Hospital) - Treatment initiation January 1st, 2008, to December 31st, 2022 Exclusion Criteria: - Not meeting inclusion criteria

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Rasmus Møller Duus Odense

Sponsors (3)
Lead Sponsor Collaborator
University of Southern Denmark Odense Patient Data Explorative Network, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of invasive mold infection in childhood AML and ALL in Denmark The number of subjects in the cohort infected with an invasive mold during leukemia treatment period as defined by the European Organization for Research and Treatment of Cancer Mycoses study group (EORTC/MSG) criteria Up to three years
Primary Mortality form invasive mold infection in childhood AML and ALL in Denmark. The number of subjects in the cohort dying from an invasive mold infection during their leukemia treatment period Up to three years
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