Biomarkers of Cytomegalovirus Fetal Infection and Disease

NCT03090841 | Unknown

• 1 other identifier: 14024
• Study Type: observational
• Target: 265
• Locations: 1 country
• Sites: 1

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.

Conditions

Cytomegalovirus Congenital

Keywords

Cytomegalovirus Congenital; Non-invasive diagnosis; Omics; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Abnormal Laboratory Values in fetal blood

  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

  At 23 weeks gestation +/- 3 weeks

Secondary Outcomes (2)

• Number of Participants With Abnormal Laboratory Values in amniotic fluid

  At 23 weeks gestation +/- 3 weeks

• Non invasive diagnosis of fetal CMV infection in maternal blood in UI/mL.

  At 23 weeks gestation +/- 5 weeks

Study Arms (2)

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

Interventions

Bio-specimen collected BIOLOGICAL

CMV cases; Control cases

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Necker Enfants-Malades

Paris, 75015, France

RECRUITING

Related Publications (4)

• Benoist G, Salomon LJ, Jacquemard F, Daffos F, Ville Y. The prognostic value of ultrasound abnormalities and biological parameters in blood of fetuses infected with cytomegalovirus. BJOG. 2008 Jun;115(7):823-9. doi: 10.1111/j.1471-0528.2008.01714.x.

  PMID: 18485159 BACKGROUND

• Fabbri E, Revello MG, Furione M, Zavattoni M, Lilleri D, Tassis B, Quarenghi A, Rustico M, Nicolini U, Ferrazzi E, Gerna G. Prognostic markers of symptomatic congenital human cytomegalovirus infection in fetal blood. BJOG. 2011 Mar;118(4):448-56. doi: 10.1111/j.1471-0528.2010.02822.x. Epub 2010 Dec 24.

  PMID: 21199291 BACKGROUND

• Desveaux C, Klein J, Leruez-Ville M, Ramirez-Torres A, Lacroix C, Breuil B, Froment C, Bascands JL, Schanstra JP, Ville Y. Identification of Symptomatic Fetuses Infected with Cytomegalovirus Using Amniotic Fluid Peptide Biomarkers. PLoS Pathog. 2016 Jan 25;12(1):e1005395. doi: 10.1371/journal.ppat.1005395. eCollection 2016 Jan.

  PMID: 26808779 BACKGROUND

• Bourgon N, Fitzgerald W, Aschard H, Magny JF, Guilleminot T, Stirnemann J, Romero R, Ville Y, Margolis L, Leruez-Ville M. Cytokine Profiling of Amniotic Fluid from Congenital Cytomegalovirus Infection. Viruses. 2022 Sep 28;14(10):2145. doi: 10.3390/v14102145.

  PMID: 36298700 DERIVED

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

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Yves VILLE, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne LERUEZ, MD, PhD

CONTACT

+33 (0) 1 44 49 49 49 62; marianne.leruez@aphp.fr

Hélène MOREL

CONTACT

+33 1 71 19 63 46; helene.morel@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: March 27, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: November 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)