Childhood CancerNCT04669418
Host RNA Signature in Children With Cancer and Infection
An observational study of Childhood Cancer and Infection, run by Copenhagen University Hospital, Rigshospitalet at 5 sites in Denmark.
Trial summary
The aim is to investigate if RNA expression signature can discriminate bacterial from viral infection or non-infectious inflammation in children with cancer. Earlier studies in immunocompetent children have shown promising results, but studies in immunocompromised children are lacking. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Childhood Cancer, Infection, Neutropenia, Febrile
- What is being tested?
- RNA expression signature
- How many people
- 370 participants
- Where
- 5 sitesDenmark
- Study dates
- 1 Jun 2019to 31 Jul 2021
- 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: Children with cancer and fever admitted to the Pediatric Oncology Departments throughout Denmark.
Who may be able to join
- Children with cancer and fever. Fever defined as temperature above 38.5 °C measured once, or 38.0-38.5 °C for ≥ 1 hour.
Who cannot join
- The children can be excluded if they turn out to have a different diagnosis than expected or if it is not possible to draw the blood tests.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Department of Pediatrics, Aalborg University Hospital
Aalborg, 9000
Department of Pediatric Oncology, Aarhus University Hospital
Aarhus, 8200
Center for Genomic Medicine
Copenhagen, 2100
Department of pediatric and adolescent medicine, Rigshospitalet (Copenhagen University Hospital)
Copenhagen, 2100
Department of Pediatrics, The H.C. Andersen's Children's hospital
Odense, 5000
About this study
Official title: Host RNA Signature to Discriminate Bacterial From Viral Infection and Non-specific Inflammation in Children With Cancer
The aim is to investigate if RNA expression signature can discriminate bacterial from viral infection or non-infectious inflammation in children with cancer.
Earlier studies in immunocompetent children have shown promising results, but studies in immunocompromised children are lacking.
We aim to include 300 febrile episodes in children with cancer. The samples will be analysed by RNA sequencing. If succesfull, this method can help prevent unnecessary antibiotic treatment, reduce hospital admissions, side effects and antimicrobial resistance and improve quality of life for children during cancer treatment.
Read the detailed description
Children with cancer are at high risk of invasive bacterial infections particularly during neutropenia. Febrile neutropenia is an early sign of a potentially fatal infection requiring broad-spectrum empiric antibiotics. However, the majority of children do not have a bacterial infection, but still receive antibiotics, since current tests cannot distinguish causes of fever. A number of transcriptomic studies of immunocompetent patients show that host leukocyte patterns of activated RNA can discriminate bacterial infection from non-infectious inflammation with high accuracy, but studies in immunocomprised patients are few.
Methods
A prospective non-interventional observational multicentre study including febrile childhood cancer patients during 24 months at all Danish Pediatric Oncology Departments (Rigshospitalet, Aarhus, Odense and Aalborg University Hospitals). Leukocyte RNA expression will be analysed in whole blood samples by RNA sequencing adjusted for low RNA input. 300 febrile episodes will be included, and predictive host RNA signatures will be identified in a discovery cohort and assessed in a validation cohort. Further, to explore the transcriptome in non-febrile children with neutropenia, we include a control group of 15 children with cancer and no fever.
Time frame Inclusion of children: 1st of June 2019 to 31st of May 2021 Analysis of samples (RNA sequencing): 1st of June 2021 - 1st of December 2021
Perspective
The study will create a base for a randomised trial regarding implementation of RNA signature versus normal procedure in handling febrile children with cancer. This can lead to the development of a targeted RNA-expression analytical platform that can prevent unnecessary antibiotic treatment in the majority of children with febrile neutropenia. This will reduce hospital admissions, side effects, antimicrobial resistance and improve quality of life during cancer treatment. The results can be extrapolated to the adult patients with cancer, who are often treated with prophylactic antibiotics, which complicate finding the infectious agent. Additionally, the test may be applied in other immunosuppressed children with infections.
- Conditions
- Childhood Cancer, Infection, Neutropenia, Febrile
- Being tested
- RNA expression signature
- Medical subject headings
- Neoplasms, Infections, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNA expression signatureDiagnostic test
Whole transcriptome profiling using RNA sequencing
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 70 children with cancer and a positive blood culture. Receives: Diagnostic Test: RNA expression signature | |
| Group 2 | 50 children with cancer and no positive blood culture. Receives: Diagnostic Test: RNA expression signature |
What is being measured
The primary outcome is the main question the study is designed to answer.
RNA signature
To detect specific RNA signatures in whole blood in children with febrile neutropenia
Measured: 1.5 years
Secondary outcomes (4)
Time study
An investigation of the change in RNA expression over time during an infection period
Measured: 1,5 years
Application of known RNA signatures
To test RNA signatures from genes published in other studies eg. the genes IFI44L and FAM89A
Measured: 1,5 years
Differences in RNA signature according to pathogen
To investigate potential differences in RNA signatures in patients with gram positive versus gram negative bacteria
Measured: 1,5 years
Comparishment of RNA signatures in neutropenic and non-neutropenic children
To compare RNA signatures in febrile neutropenic and non-neutropenic children with a positive blood culture
Measured: 1,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start1 Jun 2019
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Børnecancerfonden, Lundbeck Foundation, Danish Cancer Society
- Responsible party
- Principal investigator, Lotte Møller Smedegaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lotte M. Smedegaard, M.D., Principal investigator, ph.d.-student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669418
- Sponsor's protocol ID
- H-2-2010-002_1
- Status last verified
- Dec 2022
- First submitted
- 9 Dec 2020
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Host RNA Signature to Discriminate Bacterial From Viral Infection and Non-specific Inflammation in Children With Cancer
- ClinicalTrials.gov ID
- NCT04669418
- Acronym / sponsor ID
- H-2-2010-002_1
- Conditions
- Childhood Cancer, Infection, Neutropenia, Febrile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Børnecancerfonden, Lundbeck Foundation, Danish Cancer Society
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 16 Dec 2020 (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 aim is to investigate if RNA expression signature can discriminate bacterial from viral infection or non-infectious inflammation in children with cancer.
Earlier studies in immunocompetent children have shown promising results, but studies in immunocompromised children are lacking.
We aim to include 300 febrile episodes in children with cancer. The samples will be analysed by RNA sequencing. If succesfull, this method can help prevent unnecessary antibiotic treatment, reduce hospital admissions, side effects and antimicrobial resistance and improve quality of life for children during cancer treatment.
Detailed description
Children with cancer are at high risk of invasive bacterial infections particularly during neutropenia. Febrile neutropenia is an early sign of a potentially fatal infection requiring broad-spectrum empiric antibiotics. However, the majority of children do not have a bacterial infection, but still receive antibiotics, since current tests cannot distinguish causes of fever. A number of transcriptomic studies of immunocompetent patients show that host leukocyte patterns of activated RNA can discriminate bacterial infection from non-infectious inflammation with high accuracy, but studies in immunocomprised patients are few.
Methods
A prospective non-interventional observational multicentre study including febrile childhood cancer patients during 24 months at all Danish Pediatric Oncology Departments (Rigshospitalet, Aarhus, Odense and Aalborg University Hospitals). Leukocyte RNA expression will be analysed in whole blood samples by RNA sequencing adjusted for low RNA input. 300 febrile episodes will be included, and predictive host RNA signatures will be identified in a discovery cohort and assessed in a validation cohort. Further, to explore the transcriptome in non-febrile children with neutropenia, we include a control group of 15 children with cancer and no fever.
Time frame Inclusion of children: 1st of June 2019 to 31st of May 2021 Analysis of samples (RNA sequencing): 1st of June 2021 - 1st of December 2021
Perspective
The study will create a base for a randomised trial regarding implementation of RNA signature versus normal procedure in handling febrile children with cancer. This can lead to the development of a targeted RNA-expression analytical platform that can prevent unnecessary antibiotic treatment in the majority of children with febrile neutropenia. This will reduce hospital admissions, side effects, antimicrobial resistance and improve quality of life during cancer treatment. The results can be extrapolated to the adult patients with cancer, who are often treated with prophylactic antibiotics, which complicate finding the infectious agent. Additionally, the test may be applied in other immunosuppressed children with infections.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: RNA expression signature70 children with cancer and a positive blood culture. |
| Group 2 | – | Diagnostic Test: RNA expression signature50 children with cancer and no positive blood culture. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with cancer and fever admitted to the Pediatric Oncology Departments throughout Denmark.
Key inclusion criteria (1 listed)
- Children with cancer and fever. Fever defined as temperature above 38.5 °C measured once, or 38.0-38.5 °C for ≥ 1 hour.
Key exclusion criteria (1 listed)
- The children can be excluded if they turn out to have a different diagnosis than expected or if it is not possible to draw the blood tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RNA expression signatureWhole transcriptome profiling using RNA sequencing | Diagnostic test | Group 1, Group 2 |
Primary outcome
RNA signature
Time frame: 1.5 years
To detect specific RNA signatures in whole blood in children with febrile neutropenia
4 secondary outcomes
Time study
Time frame: 1,5 years
Application of known RNA signatures
Time frame: 1,5 years
Differences in RNA signature according to pathogen
Time frame: 1,5 years
Comparishment of RNA signatures in neutropenic and non-neutropenic children
Time frame: 1,5 years
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 22 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
Lotte M. Smedegaard, M.D. principal investigator
ph.d.-student
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Cancer and Infection, run by Copenhagen University Hospital, Rigshospitalet at 5 sites 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 1 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 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
RNA signature (time frame: 1.5 years). 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 22 Dec 2022.