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NCT05774990Completed

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

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

Source: ClinicalTrials.gov · Last updated 14 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
621 (actual)
First submitted
7 Mar 2023
Start date
1 Apr 2023
Primary completion date
26 Oct 2025
Lead sponsor
University of Southern Denmark
NCT number
NCT05774990

What you commit to

  • Study type: Observational
  • Participants enrolled: 621
  • From 1 Apr 2023 to the primary completion date, 26 Oct 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Not meeting inclusion criteria

Who the study is looking for

  • 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

Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Rasmus Møller Duus
Coordinator of this site? Confirm its status
OdenseDenmarkUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.