Protein Biomarkers and Host RNA Expression Profiles in Congenital Cytomegalovirus Infection

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for children born in Denmark between 1 January 2010 and 31 December 2025 who have a stored newborn dried blood spot sample. It includes children with congenital CMV infection (CMV caught before birth) and children without it, for comparison.

Életkor

0 Days to 28 Days (age at newborn blood spot sampling)

Nem

All sexes

A betegség stádiuma

Cases: children with confirmed congenital CMV infection. Comparison children: no sign of congenital CMV infection, similar in sex, gestational age, birthweight and age at sampling.

Biomarker vagy leletérték

Cases need a positive CMV PCR test on a newborn dried blood spot, blood or urine taken in the newborn period.

A részvétel fő kizáró okai

• Dried blood spot sample not approved for research use
• Not enough blood in the sample for RNA or protein tests
• Sample of poor quality for laboratory tests

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

This study seeks to identify and test host protein biomarkers and RNA expression profiles in dried blood spot samples as novel diagnostic markers of congenital cytomegalovirus sequelae and to improve the understanding of the pathogenesis of the disease.

A vizsgálat 3 csoportja

• Cases

  300 children with symptomatic congenital CMV infection. Study procedures: Diagnostic/prognostic test and disease pathogenesis: Host RNA expression profiling by RNA sequencing and proteomic analyses. Cases will be randomly assigned to a "Discovery Cohort" for identification of diagnostic/prognostic RNA and proteomic profiles). Disease pathogenesis: Host RNA expression profiling by RNA sequencing and proteomic analyses will be performed to explore disease pathogenesis.

• Control group 1

  300 children without congenital CMV infection. Study procedures: Diagnostic/prognostic test and disease pathogenesis: Host RNA expression profiling by RNA sequencing and proteomic analyses. Cases will be randomly assigned to a "Discovery Cohort" for identification of diagnostic/prognostic RNA and proteomic profiles). Disease pathogenesis: Host RNA expression profiling by RNA sequencing and proteomic analyses will be performed to explore disease pathogenesis.

• Control group 2

  30 neonates with asymptomatic congenital CMV infection and no sequelae Study procedures: Diagnostic/prognostic test and disease pathogenesis: Host RNA expression profiling by RNA sequencing and proteomic analyses. Cases will be randomly assigned to a "Discovery Cohort" for identification of diagnostic/prognostic RNA and proteomic profiles). Disease pathogenesis: Host RNA expression profiling by RNA sequencing and proteomic analyses will be performed to explore disease pathogenesis.