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Host RNA Signature in Children With Cancer and Infection

NCT ID: NCT04669418

Last Updated: 2022-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

370 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2021-07-31

Brief Summary

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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

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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

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Childhood Cancer Infection Neutropenia, Febrile

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

70 children with cancer and a positive blood culture.

RNA expression signature

Intervention Type DIAGNOSTIC_TEST

Whole transcriptome profiling using RNA sequencing

Group 2

50 children with cancer and no positive blood culture.

RNA expression signature

Intervention Type DIAGNOSTIC_TEST

Whole transcriptome profiling using RNA sequencing

Interventions

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RNA expression signature

Whole transcriptome profiling using RNA sequencing

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Børnecancerfonden

OTHER

Sponsor Role collaborator

Lundbeck Foundation

OTHER

Sponsor Role collaborator

Danish Cancer Society

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Lotte Møller Smedegaard

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lotte M. Smedegaard, M.D.

Role: PRINCIPAL_INVESTIGATOR

ph.d.-student

Locations

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Department of Pediatrics, Aalborg University Hospital

Aalborg, , Denmark

Site Status

Department of Pediatric Oncology, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Center for Genomic Medicine

Copenhagen, , Denmark

Site Status

Department of pediatric and adolescent medicine, Rigshospitalet (Copenhagen University Hospital)

Copenhagen, , Denmark

Site Status

Department of Pediatrics, The H.C. Andersen's Children's hospital

Odense, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-2-2010-002_1

Identifier Type: -

Identifier Source: org_study_id