Leukemia, Myeloid, AcuteNCT05774990
Study Protocol: Study on Incidence and Risk Factors of Mold Infections in Children During Leukemia Treatment
An observational study of Leukemia, Myeloid, Acute and Acute Lymphoblastic Leukemia, run by University of Southern Denmark at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Leukemia, Myeloid, Acute, Acute Lymphoblastic Leukemia
- How many people
- 621 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2023to 26 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- Not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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
- 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.
- Keywords
- leukemia, childhood, myeloid, lymphoblastic, pediatric, invasive, mold, aspergillus
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start1 Apr 2023
- Primary completion26 Oct 2025
- Study completion26 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 621 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Odense Patient Data Explorative Network
- Responsible party
- Sponsor
- Investigators
- Rasmus Møller Duus, MD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774990
- Sponsor's protocol ID
- 22/15850
- Status last verified
- May 2026
- First submitted
- 7 Mar 2023
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data that underlie the results in a future publication will be made publicly available in an anonymized form.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05774990
- Acronym / sponsor ID
- 22/15850
- Keywords
- leukemia, childhood, myeloid, lymphoblastic, pediatric, invasive, mold, aspergillus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 621 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, Odense Patient Data Explorative Network
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 26 Oct 2025 (actual)
- Study completion
- 26 Oct 2025 (actual)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Yes. All individual participant data that underlie the results in a future publication will be made publicly available in an anonymized form.
Related trials for Leukemia, Myeloid, Acute
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rasmus Møller Duus, MD principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Myeloid, Acute and Acute Lymphoblastic Leukemia, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of invasive mold infection in childhood AML and ALL in Denmark (time frame: Up to three years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.