NCT02965287

Validation of a Test for Fetal Malformations

Blind Validation of a Metabolomics Based Test for the Non-invasive Screening of Fetal Malformations

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,943 (estimated)
• Sponsor: Theoreo Srl · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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 (www.scopestudy.net), 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.

Conditions

• Fetal Anomaly

Interventions

Type	Name	Description
OTHER	Serum metabolomics profiling	The serum samples will be used to get a metabolomic profile

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-11-16
• Last updated: 2018-03-22

Locations

1 site across 1 country: Italy