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

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

NCT ID: NCT05774990

Condition: Leukemia, Myeloid, Acute
Acute Lymphoblastic Leukemia

Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid
Leukemia, Myeloid, Acute

Conditions: Keywords:
leukemia
childhood
myeloid
lymphoblastic
pediatric
invasive
mold
aspergillus

Study type: Observational

Overall status: Active, not recruiting

Study design:

Time perspective: Retrospective

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.

Criteria for eligibility:

Study pop:
Any patient (<18 years) who initiated first-line chemotherapy against primary ALL or AML at any of the four Danish pediatric oncology departments from January 1st, 2008, to December 31st, 2022.

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: N/A

Maximum age: 17 Years

Healthy volunteers: No

Locations:

Facility:
Name: Rasmus Møller Duus

Address:
City: Odense
Zip: DK-5000
Country: Denmark

Start date: April 1, 2023

Completion date: August 2025

Lead sponsor:
Agency: University of Southern Denmark
Agency class: Other

Collaborator:
Agency: Odense University Hospital
Agency class: Other

Collaborator:
Agency: Odense Patient Data Explorative Network
Agency class: Other

Source: University of Southern Denmark

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05774990