Clinical Trial: Biomarkers of Cytomegalovirus Fetal Infection and Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief 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 Summary:

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

Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Number of Participants With Abnormal Laboratory Values in fetal blood [ Time Frame: At 23 weeks gestation +/- 3 weeks ]

Fetal platelet in mm3/ml, β2 microglobulinein mg/L, proteins concentration in mg/L , Metabolites concentration in mmoles/l , Lipids concentration in mmoles/l , RNA messagers concentration in µg/ml profil


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of Participants With Abnormal Laboratory Values in amniotic fluid [ Time Frame: At 23 weeks gestation +/- 3 weeks ]
    CMV DNA quantification in UI/mL , protein concentration in mg/L, Metabolites concentration in mmoles/l , Lipids concentration in mmoles/l, RNAm concentration in µg/ml profil ,
  • Non invasive diagnosis of fetal CMV infection in maternal blood in UI/mL. [ Time Frame: At 23 weeks gestation +/- 5 weeks ]
    CMV fetal DNA measurement in maternal blood


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: January 3, 2017
Date Started: December 2016
Date Completion: June 2023
Last Updated: March 21, 2017
Last Verified: March 2017