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

About the study

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).

Study point of contact

David CHEILLAN, MD, PhD
04 72 12 96 88 ext +33
david.cheillan@chu-lyon.fr
Dr Céline RENOUX, MD, PhD
04.27.85.65.94 ext +33
celine.renoux@chu-lyon.fr

Locations

3 France sites

Age

< 27 Years

Study type

Observational

Gender

All

Interventions

Other

Compensation

Unknown

participation requirements

– Infants with SCD newborn screening conducted in the hospital center of Lyon

participation restrictions

– Insufficient quantity of sampling

– Parents’ opposition to their newborn’s participation in the study

Locations

  • Bron, France, Groupement Hospitalier Est - Hospices Civils de Lyon, 69677 [Not yet recruiting]
  • Lyon, France, Hôpital de la Croix Rousse, 69317 [Not yet recruiting]
  • Pierre-Bénite, France, Centre Hospitalier Lyon Sud, 69495 [Recruiting]
Last updated 2021-03-19