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Validation of a Test for Fetal Malformations

NCT02965287 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1943

Last updated 2018-03-22

No results posted yet for this study

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.

Conditions

  • Fetal Anomaly

Interventions

OTHER

Serum metabolomics profiling

The serum samples will be used to get a metabolomic profile

Sponsors & Collaborators

  • Auckland UniServices Ltd.

    collaborator INDUSTRY

  • Massachusetts General Hospital

    collaborator OTHER

  • Theoreo Srl

    lead INDUSTRY

Principal Investigators

  • Jacopo Troisi, Dr. · CEO

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02965287 on ClinicalTrials.gov