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NCT Number: NCT04669418

Host RNA Signature in Children With Cancer and Infection

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.

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Key information

Conditions

Childhood Cancer Agranulocytosis Cytopenia Febrile Neutropenia Hematologic Diseases Hemic and Lymphatic Diseases Infection Infections Leukocyte Disorders Leukopenia Neoplasms Neutropenia Neutropenia, Febrile

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pediatrics, Aalborg University Hospital, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children with cancer and fever. Fever defined as temperature above 38.5 °C measured once, or 38.0-38.5 °C for ≥ 1 hour.

Exclusion criteria

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.

Treatment and study plan

RNA expression signature

Diagnostic Test

Whole transcriptome profiling using RNA sequencing

Primary outcomes

  1. RNA signature

    Time frame: 1.5 years

    To detect specific RNA signatures in whole blood in children with febrile neutropenia

Secondary outcomes

  1. Time study

    Time frame: 1,5 years

    An investigation of the change in RNA expression over time during an infection period

  2. Application of known RNA signatures

    Time frame: 1,5 years

    To test RNA signatures from genes published in other studies eg. the genes IFI44L and FAM89A

  3. Differences in RNA signature according to pathogen

    Time frame: 1,5 years

    To investigate potential differences in RNA signatures in patients with gram positive versus gram negative bacteria

  4. Comparishment of RNA signatures in neutropenic and non-neutropenic children

    Time frame: 1,5 years

    To compare RNA signatures in febrile neutropenic and non-neutropenic children with a positive blood culture

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Børnecancerfonden
  • Danish Cancer Society
  • Lundbeck Foundation

Registry information

Official study title

Host RNA Signature to Discriminate Bacterial From Viral Infection and Non-specific Inflammation in Children With Cancer

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 16, 2020
Registry last updated
Dec 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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