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

NCT05774990 | Active Not Recruiting

• 1 other identifier: 22/15850
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia, Myeloid, Acute; Acute Lymphoblastic Leukemia

Keywords

leukemia; childhood; myeloid; lymphoblastic; pediatric; invasive; mold; aspergillus

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead
• Odense University Hospital: collaborator
• Odense Patient Data Explorative Network: collaborator

Study Sites (1)

Rasmus Møller Duus

Odense, DK-5000, Denmark

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Rasmus Møller Duus, MD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 20, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The study protocol will be available before collecting participant data. The anonymized participant data will be made available as supplementary material simultaneously with the publication of the article.
• Access Criteria: All who have access to the article can access the participant data.

Locations

DK (1)