November, 11 2019

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

Locations

3 France sites

Age

< 27 Years

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 Type

Observational

Age

< 27 Years

Gender

All

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

Interventions

  • Other

Outcome measures

  • Percent agreement between the two techniques

Location

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

Contact Research Team

  • David CHEILLAN, MD, PhD
    04 72 12 96 88 ext +33
  • Dr Céline RENOUX, MD, PhD
    04.27.85.65.94 ext +33

More info

View on ClinicalTrials
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