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

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 includes 621 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.

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Key information

Conditions

Leukemia, Myeloid, Acute Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myeloid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rasmus Møller Duus

Odense, DK-5000, Denmark

About this study

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

To determine and compare the incidence of IMI in childhood AML and ALL during first-line chemotherapy in Denmark.
To determine and compare the mortality of IMI in childhood AML and ALL during first-line chemotherapy in Denmark.
To explore risk factors for IMI in childhood AML and ALL during first-line chemotherapy in Denmark.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Incidence of invasive mold infection in childhood AML and ALL in Denmark

Time frame: Up to three years

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
Mortality form invasive mold infection in childhood AML and ALL in Denmark.

Time frame: Up to three years

The number of subjects in the cohort dying from an invasive mold infection during their leukemia treatment period

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

Odense Patient Data Explorative Network
Odense University Hospital

Registry information

Official study 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

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Mar 20, 2023
Registry last updated: May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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