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Early Diagnosis of the GLUT1 Deficiency Syndrome With a Blood Based Test

NCT03722212 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 636

Last updated 2022-12-01

No results posted yet for this study

Summary

The study aims at validating the diagnostic performances of the METAglut1, a blood in vitro diagnostic test, for the simple and early diagnosis of the Glut1 deficiency syndrome (Glut1DS, or De Vivo disease).

The blood test will be carried out prospectively on patients presenting with a clinical suspicion of Glut1DS, blindly from the reference strategy, which consists in a lumbar puncture for glycorrhachia measurement, completed by a molecular analysis.

The study will be conducted in more than 40 centers in France on up to 3,000 patients for 2 years.

Conditions

Interventions

DIAGNOSTIC_TEST

METAglut1

A blood draw is performed on each patient for the METAglut1 test, and sent to Laboratoire CERBA, Saint-Ouen l'Aumône, France, for sample analysis.

Sponsors & Collaborators

  • European Commission

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    collaborator OTHER

  • Cemka-Eval

    collaborator OTHER

  • Ministry for Health and Solidarity, France

    collaborator OTHER_GOV

  • French National Authority for Health

    collaborator UNKNOWN

  • METAFORA biosystems

    lead INDUSTRY

Principal Investigators

  • Fanny Mochel, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-24
Primary Completion
2021-03-31
Completion
2021-07-09

Countries

  • France

Study Locations

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Diseases
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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 NCT03722212 on ClinicalTrials.gov