Host RNA Signature in Children With Cancer and Infection

NCT04669418 | Completed DMC

• 1 other identifier: H-2-2010-002_1
• Study Type: observational
• Target: 370
• Locations: 1 country
• Sites: 5

Brief 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. 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.

Conditions

Childhood Cancer; Infection; Neutropenia, Febrile

Outcome Measures

Primary Outcomes (1)

• RNA signature

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

  1.5 years

Secondary Outcomes (4)

• Time study

  1,5 years

• Application of known RNA signatures

  1,5 years

• Differences in RNA signature according to pathogen

  1,5 years

• Comparishment of RNA signatures in neutropenic and non-neutropenic children

  1,5 years

Study Arms (2)

Group 1

70 children with cancer and a positive blood culture.

Diagnostic Test: RNA expression signature

Group 2

50 children with cancer and no positive blood culture.

Diagnostic Test: RNA expression signature

Interventions

RNA expression signature DIAGNOSTIC_TEST

Whole transcriptome profiling using RNA sequencing

Group 1; Group 2

Eligibility Criteria

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

Study Population

Children with cancer and fever admitted to the Pediatric Oncology Departments throughout Denmark.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Børnecancerfonden: collaborator
• Lundbeck Foundation: collaborator
• Danish Cancer Society: collaborator

Study Sites (5)

Department of Pediatrics, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Department of Pediatric Oncology, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Center for Genomic Medicine

Copenhagen, 2100, Denmark

Location

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

Copenhagen, 2100, Denmark

Location

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

Odense, 5000, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

All children will have 2.5 ml whole blood drawn into a PaxGene RNA (Qiagen®) tube along with routine blood tests. Only RNA is extracted

MeSH Terms

Conditions

Neoplasms; Infections; Febrile Neutropenia

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Lotte M. Smedegaard, M.D.

  ph.d.-student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 16, 2020
• Study Start: June 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: December 22, 2022

Record last verified: 2022-12

Locations

DK (5)