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Biomarkers of Cytomegalovirus Fetal Infection and Disease (BIO-CCMV)

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ClinicalTrials.gov Identifier: NCT03090841
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.

Condition or disease Intervention/treatment
Cytomegalovirus Congenital Biological: Bio-specimen collected

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
Study Design
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Study Type : Observational
Estimated Enrollment : 265 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers of Fetal Infection and Disease Following Maternal HCMV Infection
Study Start Date : December 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
CMV cases
bio-specimen collected for pregnant women with CMV infection
 Biological: Bio-specimen collected
Control cases
bio-specimen collected for pregnant women carrying a fetus with aneuploidy-dysgonosomy
 Biological: Bio-specimen collected


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ,

  2. 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


Biospecimen Retention:   Samples With DNA
  • Amniotic fluid (2ml)
  • Fetal blood (2 ml)
  • Maternal blood (5 ml)
  • Cord blood (50 ml)
  • Neonatal blood (2 ml)
  • Neonatal urine (2 ml

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • 320 pregnant women with CMV primary infection or carrying a fetus with compatible ultrasound features to obtained 65 infected fetuses and 15 fetuses diagnosed with severely symptomatic infection
  • 200 controls pregnant women carrying a fetus with aneuploidy-dysgonosomy
Criteria

Inclusion Criteria:

CMV cases:

  • Informed consent obtained from the mother;
  • Pregnant women either with a history of primary CMV infection in pregnancy or carrying a fetus with ultrasound features compatible with CMV infection and willing to have amniocentesis for fetal diagnosis of CMV infection

Control cases :

- Pregnant women carrying a fetus with aneuploidy-dysgonosomy

Exclusion Criteria:

CMV cases:

  • Fetuses older than the 26 weeks of gestation at the time of diagnosis of HCMV infection or impossibility to collect foetal samples by the end of the 26th week of gestation
  • Mother unable to understand the protocol
  • Absence of informed consent
  • Any clinical rationale not to perform cordocentesis
  • Mother <18 years age
  • Administration of immunoglobulins or anti-viral therapy to the mother before the collection of fetal samples or before the diagnosis of symptomatic fetal infection
  • Administration of anti-HCMV drugs to the foetus before the collection of fetal samples or before the diagnosis of symptomatic fetal infection
  • Administration of immunosuppressive drugs to the mother during pregnancy
  • Maternal auto immune disorders
  • Multiple pregnancies.

Control cases :

  • Mother unable to understand the protocol
  • Absence of informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090841


Contacts
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Contact: Marianne LERUEZ, MD, PhD +33 (0) 1 44 49 49 49 62 marianne.leruez@aphp.fr
Contact: Laurence LECOMTE, PhD +33 1 71 19 64 94 laurence.lecomte@aphp.fr

Locations
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France
Hôpital Necker Enfants-Malades Recruiting
Paris, France, 75015
Contact: Marianne LERUEZ, MD, PhD    +33 (0) 1 44 49 49 49 62    marianne.leruez@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Yves VILLE, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information
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Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03090841    
Other Study ID Numbers: 14024
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cytomegalovirus Congenital
Non-invasive diagnosis
Omics
Biomarkers