Sickle Cell Disease Clinical Trial
— DREPAMASSEOfficial title:
DREPAMASSE Study - Evaluation of a Newborn Screening for Sickle Cell Disease by Tandem Mass Spectrometry
Verified date | April 2024 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Three methods are actually used in newborn screening for sickle cell disease (SCD) in France: isoelectric focusing, high performance liquid chromatography and capillary electrophoresis. New technologies are currently under development such as Matrix Assisted Laser Desorption Ionisation - Time of Flight (MALDI-TOF) and tandem mass spectrometry (MS/MS) using the SpOtOn Diagnostics Reagent Kit available in United Kingdom only. Zentech company (Liège, Belgium) is developing a package for SCD newborn screening using MS/MS technology. The main objective of the present study will be to compare this new technique with the technique actually used in the hospital center of Lille (sub-contractor for SCD newborn screening of Lyon) and the haemoglobin analysis to test its accuracy (sensitivity and specificity).
Status | Completed |
Enrollment | 1431 |
Est. completion date | December 10, 2022 |
Est. primary completion date | December 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 27 Days |
Eligibility | Inclusion Criteria: - Infants with SCD newborn screening conducted in the hospital center of Lyon Exclusion Criteria: - Insufficient quantity of sampling - Parents' opposition to their newborn's participation in the study |
Country | Name | City | State |
---|---|---|---|
France | Groupement Hospitalier Est - Hospices Civils de Lyon | Bron | |
France | Hopital de la Croix Rousse | Lyon | |
France | Centre Hospitalier Lyon Sud | Pierre-Bénite |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent agreement between the two techniques | Non-inferiority (difference <1%) in terms of sensitivity and specificity between the results obtained with the MS/MS method and those obtained with the technique currently used at the Lille CHU (sub-contractor for SCD newborn screening of Lyon) | 6 months |
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