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NCT03985501 Clinical Trial

DREPAMASSE Study - Evaluation of a Newborn Screening for Sickle Cell Disease by Tandem Mass Spectrometry

Sickle Cell Disease Clinical Trial

— DREPAMASSE  

Official title:
DREPAMASSE Study - Evaluation of a Newborn Screening for Sickle Cell Disease by Tandem Mass Spectrometry

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03985501
Other study ID # 69HCL19_0338
Secondary ID 2019-A01346-51
Status Completed
Phase
First received
Last updated
Start date March 16, 2021
Est. completion date December 10, 2022

Study information
Verified date April 2024
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• SCD newborn screening with the MS/MS method from Zentech
The analysis of the SCD newborn screening with the MS/MS method from Zentech will be realized after achievement and biological validation of the SCD newborn screening in the usual care pathway. The results will be compared with the method used at the Lille Academic Hospital (CHU Lille) (sub-contractor for SCD newborn screening of Lyon)

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
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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