Ignite Creation Date:
2024-05-06 @ 9:23 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02965287
Status:
COMPLETED
Last Update Posted:
2018-03-22
First Post:
2016-11-14
Brief Title:
Validation of a Test for Fetal Malformations
Sponsor:
Theoreo Srl
Organization:
Theoreo Srl
Study Overview
Official Title:
Blind Validation of a Metabolomics Based Test for the Non-invasive Screening of Fetal Malformations
Status:
COMPLETED
Status Verified Date:
2017-10
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:
None
Brief Summary:
The investigators have developed a diagnostic test for the evaluation of the presence of fetal malformations through metabolomic analysis of maternal peripheral blood serum by chromatographic techniques and mass spectrometry and subsequent mathematical modeling analysis of the data by means of multivariate mathematical models specifically developed for this purpose The study aims at determining the performance parameters specificity sensibility positive predictive value PPN negative predictive value NPV etc of the test and its applicability To do this the investigators will use the serum samples of the patients enrolled in New Zealand in the SCOPE Study wwwscopestudynet an international study conducted between years 2004-2008
Detailed Description:
The test has been developed in a case-control study In this clinical trial the investigators will test it in a large cohort that is likely to resemble a real population The purpose of validation is to see if the test is able to recognize the few malformed fetuses in the entire population and especially its specificity in real conditions In addition the investigators will check whether particular maternal conditions such as preeclampsia gestational diabetes etc or fetal conditions Small for gestational age Large for gestational age etc affect the test results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None