Trials / Unknown
UnknownNCT03090841
Biomarkers of Cytomegalovirus Fetal Infection and Disease
Biomarkers of Fetal Infection and Disease Following Maternal HCMV Infection
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 265 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purposes of this study are to determine 1) if the diagnosis of CMV fetal infection could be done directly in the maternal blood instead of requesting an amniocentesis and 2) if innovative technologies such as proteomic, transcriptomic, methylomic and lipidomic applied in fetal samples could allow the discovery of new biomarkers of fetal infection.
Detailed description
Human cytomegalovirus (HCMV) is the most common cause of congenital infection worldwide. The diagnosis of CMV fetal infection relies on the detection of viral DNA in amniotic fluid by polymerase chain reaction after amniocentesis. Non-invasive diagnosis of fetal infection directly in maternal blood is not available. Symptoms develop in about 10% of HCMV-infected fetuses. Despite important advance in medical imaging, establishing the prognosis of an infected fetus remains challenging. Thrombocytopenia, blood HCMV DNA, anti-HCMV immunoglobulin M and β2-microglobulin are recognized biomarkers of symptomatic fetal infections. However, the predictive value of these individual markers is not. Omics technologies could help to establish multimarker signatures of symptomatic infections. The objective of the study is to: * validate fetal blood HCMV DNA, anti-HCMV immunoglobulin M , β2-microglobulin and platelet count as biomarkers of fetal disease; * identify new biomarkers of severe fetal disease using transcriptomic, methylomic and lipidomic analyses of fetal blood and of amniotic fluid. * validate a non-invasive CMV fetal infection diagnosis tool based on deep-sequencing of targeted CMV genes in maternal blood
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Bio-specimen collected |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2022-12-01
- Completion
- 2023-06-01
- First posted
- 2017-03-27
- Last updated
- 2022-11-07
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03090841. Inclusion in this directory is not an endorsement.