NCT07635368 Protein Biomarkers and Host RNA Expression Profiles in Congenital Cytomegalovirus Infection
| NCT ID | NCT07635368 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Congenital Cytomegalovirus |
| Study Type | OBSERVATIONAL |
| Enrollment | 630 participants |
| Start Date | 2026-04-21 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 630 participants in total. It began in 2026-04-21 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Children born between 1 January 2010 and 31 December 2025 with an available neonatal dried blood spot sample collected through the Danish National Newborn Screening Program. 2. Cases: children with verified congenital CMV infection, defined as a positive CMV PCR result on neonatal dried blood spot, blood, or urine collected within the neonatal period. 3. Controls: children without evidence of congenital CMV infection selected from the same newborn screening population and matched to cases on sex, gestational age, birthweight, and age at DBS sampling. Exclusion Criteria: 1. DBS samples not approved for research use. 2. DBS samples with insufficient blood material for RNA expression profiling and/or proteomic analyses. 3. Samples with inadequate analytical quality for molecular or proteomic analyses.
Contact & Investigator
Kia Hee Schultz Dungu, MD
PRINCIPAL INVESTIGATOR
Rigshospitalet, Denmark
Frequently Asked Questions
Who can join the NCT07635368 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 28 Days, studying Congenital Cytomegalovirus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07635368 currently recruiting?
Yes, NCT07635368 is actively recruiting participants. Contact the research team at kia.hee.schultz.dungu@regionh.dk for enrollment information.
Where is the NCT07635368 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Copenhagen, Denmark.
Who is sponsoring the NCT07635368 clinical trial?
NCT07635368 is sponsored by Rigshospitalet, Denmark. The principal investigator is Kia Hee Schultz Dungu, MD at Rigshospitalet, Denmark. The trial plans to enroll 630 participants.