NCT03090841|Unknown
Biomarkers of Cytomegalovirus Fetal Infection and Disease
BIO-CCMV
Biomarkers of Fetal Infection and Disease Following Maternal HCMV Infection
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BIO-CCMV
Biomarkers of Fetal Infection and Disease Following Maternal HCMV Infection
Sponsor study identifier
observational
265
1 country
1
Study Start
December 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2016
Date type not reportedThis date has not been verified as actual or estimated.
January 3, 2017
Actual (reported)March 27, 2017
Actual (reported)December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
bio-specimen collected for pregnant women with CMV infection
bio-specimen collected for pregnant women carrying a fetus with aneuploidy-dysgonosomy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
* 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
Hôpital Necker Enfants-Malades
Paris, 75015, France
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.
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.
* Amniotic fluid (2ml) * Fetal blood (2 ml) * Maternal blood (5 ml) * Cord blood (50 ml) * Neonatal blood (2 ml) * Neonatal urine (2 ml
Yves VILLE, MD, PhD
Assistance Publique - Hôpitaux de Paris
First Submitted
January 3, 2017
First Posted
March 27, 2017
Study Start
December 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2022
Estimated (date passed)Epidemiology of Congenital Cytomegalovirus in a High HIV Prevalence Setting, South Africa
Contact the study team to confirm eligibility.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 7, 2022
Record last verified: 2022-10
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Source: ClinicalTrials.gov.
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