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NCT03985501: DREPAMASSE

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

Completed Last updated 17 April 2024
What this trial tests

trial testing SCD newborn screening with the MS/MS method from Zentech in Sickle Cell Disease in 1,431 participants. Completed in 10 December 2022.

Timeline
16 March 2021
Primary endpoint
10 December 2022
10 December 2022

Quick facts

Lead sponsorHospices Civils de Lyon
StatusCompleted
Study typeOBSERVATIONAL
Enrollment1,431
Start date16 March 2021
Primary completion10 December 2022
Estimated completion10 December 2022
Sites3 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

Adults 1 Day to 27 Days, any sex, with Sickle Cell Disease or Infant, Newborn, Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Evaluation of a New Tandem Mass Spectrometry Method for Sickle Cell Disease Newborn Screening.
    Renoux C, Roland E, Ruet S, Zouaghi S, et al · · 2024 · cited 1× · PMID 39728397 · DOI 10.3390/ijns10040077

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Other recruiting trials for Sickle Cell Disease

Currently open trials in the same condition.

Other Hospices Civils de Lyon trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03985501.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing