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

Active, not recruiting

• Conditions: Acute Lymphoblastic Leukemia; Leukemia, Myeloid, Acute

• Registration Number: NCT05774990
• Lead Sponsor: University of Southern Denmark

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-20
• Study Start: 2023-04-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-04
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 800

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of invasive mold infection in childhood AML and ALL in Denmark	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.	Up to three years	The number of subjects in the cohort dying from an invasive mold infection during their leukemia treatment period

Trial Locations

Locations (1)

Rasmus Møller Duus; 🇩🇰 Odense, Denmark