Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05900076
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2023-06-02
Brief Title:
Technical Feasibility of the cfDNA Test for Non-invasive Cytogenetic Analysis of Early Miscarriages Versus the Gold Standard Microarray
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Technical Feasibility of the Cell-free DNA Test for Non-invasive Cytogenetic Analysis of Early Miscarriages Versus the Gold Standard Microarray
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
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:
NICAEA
Brief Summary:
Among the 15 of couples who experience a spontaneous early miscarriage SEM during their pregnancy approximately 2 to 5 will suffer from recurrent SEM It is only after the third SM that they will be offered a workup to look for a predisposition to SEM This workup does not currently include a search for foetal chromosomal abnormalities that could be considered causal for this event These anomalies are responsible for approximately 50 of SEM and their detection could lead to an explanation for half of the couples currently without a diagnosis after a standard workup The diagnosis of chromosomal abnormalities can be made by karyotype analysis or by Cytogenetic Microarray Analysis CMA on the product of conception Unfortunately karyotyping has a high failure rate due to poor cell culture of samples that are often degraded or of low quantity The CMA is not always feasible due to the absence of analyzable feto-placental material linked to the use of a drug strategy for its elimination
The study of cell-free DNA of syncytiotrophoblastic origin cfDNA circulating in the maternal plasma could be a solution as it is for non-invasive prenatal screening of trisomy 21 cfDNA is detectable from 6 to 8 weeks of amenorrhea and released in the maternal blood as long as placental tissue is present in the uterus can be easily obtained by maternal venous sampling If maternal blood sampling is performed before complete removal of the product of conception then detection of foetal chromosomal abnormalities would be possible Thus if failure rates of CMA and cfDNA techniques are comparable cfDNA could be preferred as it applies for miscarriages for whom no fetoplacental material can be obtained
This study therefore proposes to compare the failure rates of the two technologies CMA and cfDNA for the detection of chromosomal abnormalities in recurrent SEM
The study of cell-free DNA of syncytiotrophoblastic origin cfDNA circulating in the maternal plasma could be a solution as it is for non-invasive prenatal screening of trisomy 21 cfDNA is detectable from 6 to 8 weeks of amenorrhea and released in the maternal blood as long as placental tissue is present in the uterus can be easily obtained by maternal venous sampling If maternal blood sampling is performed before complete removal of the product of conception then detection of foetal chromosomal abnormalities would be possible Thus if failure rates of CMA and cfDNA techniques are comparable cfDNA could be preferred as it applies for miscarriages for whom no fetoplacental material can be obtained
This study therefore proposes to compare the failure rates of the two technologies CMA and cfDNA for the detection of chromosomal abnormalities in recurrent SEM
Detailed Description:
None
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