Biomarkers of Cytomegalovirus Fetal Infection and Disease — BIO-CCMV  

Cytomegalovirus Congenital Clinical Trial

Official title: Biomarkers of Fetal Infection and Disease Following Maternal HCMV Infection

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Cytomegalovirus Congenital

• NCT number: NCT03090841
• Study type: Observational
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Marianne LERUEZ, MD, PhD
• Phone: +33 (0) 1 44 49 49 49 62
• Email: marianne.leruez@aphp.fr
• Status: Recruiting
• Start date: December 2016
• Completion date: June 2023