Ignite Creation Date:
2024-05-06 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03385499
Status:
UNKNOWN
Last Update Posted:
2018-09-25
First Post:
2017-11-03
Brief Title:
New Diagnostic Approach for Congenital Toxoplasmosis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
TOXODIAG New Diagnostic Approach for Congenital Toxoplasmosis
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOXODIAG
Brief Summary:
Caused by Toxoplasma gondii toxoplasmosis is mostly asymptomatic except in immunocompromised individuals and infants infected in utero Congenital toxoplasmosis CT results from the transplacental passage of the parasite which occurs in 30 of cases of primary infection during pregnancy Neonatal biological diagnosis of toxoplasmosis is essential in the case of i suggestive clinical signs in the newborn with no information on the serological status of the mother ii seroconversion diagnosed during pregnancy iii not or poorly followed pregnancy and iiii for enhanced effectiveness of treatments administered as soon as possible to the newborn Given the limitations of current diagnostic tests the characterization of specific immunoglobulin IgG neo-synthesized by the newborn would be of great help for an early diagnosis of CT
The main objective of the TOXODIAG project is to validate and evaluate the ELISPOT Enzyme-Linked Immunosorbent SPOT assay method for detecting in the newborn B lymphocytes LyB sensitized in utero to produce T gondii specific immunoglobulins Ig following a primary infection of the mother during the pregnancy More precisely the detection and quantification of LyB secreting IgG and IgM specific for T gondii using the ELISPOT method will be applied i to mononuclear cells of women in seroconversion following a toxoplasmic primo-infection during pregnancy and ii to cord blood mononuclear cells of newborns suspected of CT in comparison to positive and negative infection controls
To reach this goal TOXODIAG is a diagnostic multicentric prospective non-randomized comparative and controlled study It will be performed in 3 parallel groups of pregnant women performing prenatal follow-up and giving birth in the maternity wards of 3 hospitals of the AP-HP Louis MOURIER Bichat-Claude Bernard and Cochin which ensure motherchild follow-up and biological sampling with great gynecology and obstetrics expertise Sixty women will be selected and included into 3 groups according to toxoplasmic seroconversion during pregnancy n30 positive n15 or negative n15 toxoplasma serology The necessary biological material will consist in additional blood tubes which will be taken at the same time as those performed for the usual pregnancy follow-up examinations and will correspond to maternal peripheral blood at inclusion seroconversion and delivery as well as cord blood
The main objective of the TOXODIAG project is to validate and evaluate the ELISPOT Enzyme-Linked Immunosorbent SPOT assay method for detecting in the newborn B lymphocytes LyB sensitized in utero to produce T gondii specific immunoglobulins Ig following a primary infection of the mother during the pregnancy More precisely the detection and quantification of LyB secreting IgG and IgM specific for T gondii using the ELISPOT method will be applied i to mononuclear cells of women in seroconversion following a toxoplasmic primo-infection during pregnancy and ii to cord blood mononuclear cells of newborns suspected of CT in comparison to positive and negative infection controls
To reach this goal TOXODIAG is a diagnostic multicentric prospective non-randomized comparative and controlled study It will be performed in 3 parallel groups of pregnant women performing prenatal follow-up and giving birth in the maternity wards of 3 hospitals of the AP-HP Louis MOURIER Bichat-Claude Bernard and Cochin which ensure motherchild follow-up and biological sampling with great gynecology and obstetrics expertise Sixty women will be selected and included into 3 groups according to toxoplasmic seroconversion during pregnancy n30 positive n15 or negative n15 toxoplasma serology The necessary biological material will consist in additional blood tubes which will be taken at the same time as those performed for the usual pregnancy follow-up examinations and will correspond to maternal peripheral blood at inclusion seroconversion and delivery as well as cord blood
Detailed Description:
Toxoplasmosis is a cosmopolitan parasitosis that affects one third of the worlds population This infection caused by Toxoplasma gondii is mostly asymptomatic except in immunocompromised individuals and infants infected in utero Congenital toxoplasmosis CT results from the transplacental passage of the parasite which occurs in 30 of cases of primary infection during pregnancy The clinical consequences are all the more serious when fetal contamination is early death in utero premature delivery or term childbirth with perivisceral involvement and result in mainly neuro-ocular attacks in case of later contamination Pregnant women or women of childbearing age therefore constitute a group at risk and are exposed differently according to their geographical situation and food consumption Neonatal biological diagnosis of toxoplasmosis is essential in the case of i suggestive clinical signs in the newborn with no information on the serological status of the mother ii seroconversion diagnosed during pregnancy iii not or poorly followed pregnancy and iiii for enhanced effectiveness of treatments administered as soon as possible to the newborn This diagnosis is based mainly on parasite research in the neonatal amniotic fluid or placenta by PCR and or inoculation in mice as well as on serological tests Immunoglobulins Ig A and IgM do not cross the placental barrier and represent good markers of congenital infection in the newborn Nevertheless they are not specific to an acute infection and are no longer detectable at birth in cases of infections contracted by the mother before the 3rd trimester of pregnancy The detection of IgG synthesized by the child has a diagnostic value only after 6 months of life once the materno-transmitted IgG have been eliminated and the techniques comparing the IgG response profiles of the mother and the child to a plurality of toxoplasmic antigens remain difficult to interpret western blot ELIFA It is nevertheless a combination of these different tests that makes up the decision tree for a neonatal biological diagnosis of CT The characterization of specific IgG neo-synthesized by the newborn would be of great help for an early diagnosis of congenital infection by T gondii The present project consists in determining the presence in the neonate of B lymphocytes LyB sensitized in utero to produce specific IgG in case of CT This approach can be envisaged because of the maturity acquired by the fetal LyB from the end of the first trimester of pregnancy demonstrated by their ability to produce high affinity Ig in the case of maternal infection or neonatal immunization
This research is diagnostic multicentric prospective non-randomized comparative and controlled It will be performed in 3 parallel groups of pregnant women performing prenatal follow-up and giving birth in the maternity wards of 3 hospitals of the AP-HP which ensure motherchild follow-up and biological sampling with great gynecology and obstetrics expertise Sixty patients will be selected and included according to the following distribution
Positive control group women with positive toxoplasma serology 15 patients
Negative control group women with negative toxoplasma serology 15 patients
Group of women diagnosed with toxoplasmic seroconversion during pregnancy 30 patients
Non-recruiting centers will be HUPC and HUPNVS biology laboratories for the realization of serological tests and expertise in biological diagnosis and IRD UMR 216 for coordination laboratory experiments and expertise in immunology
This research is diagnostic multicentric prospective non-randomized comparative and controlled It will be performed in 3 parallel groups of pregnant women performing prenatal follow-up and giving birth in the maternity wards of 3 hospitals of the AP-HP which ensure motherchild follow-up and biological sampling with great gynecology and obstetrics expertise Sixty patients will be selected and included according to the following distribution
Positive control group women with positive toxoplasma serology 15 patients
Negative control group women with negative toxoplasma serology 15 patients
Group of women diagnosed with toxoplasmic seroconversion during pregnancy 30 patients
Non-recruiting centers will be HUPC and HUPNVS biology laboratories for the realization of serological tests and expertise in biological diagnosis and IRD UMR 216 for coordination laboratory experiments and expertise in immunology
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None