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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1431 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-16

Study Completion Date

2022-12-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Quality of Care of Children With Sickle Cell Disease (SCD) Screened at Birth in France

NCT03119922

New-borns Screening Sickle Cell Disease

COMPLETED

Screening for Renal Complications in Children and Young Adults With Major Sickle Cell Disease

NCT05211037

Anemia Sickle Cell Disease

COMPLETED NA

Transfusion Exchanges and Cognition in Sickle Cell Disease

NCT07168447

Drepanocytosis Chronic Neurological Deficiency

NOT_YET_RECRUITING

Dense Red Blood Cells in Sickle Cell Children

NCT02887118

Sickle Cell Disease

TERMINATED

Heart Arteries and Sickle Cell Disease / Coeur Artères DREpanocytose

NCT03114137

Sickle Cell Anemia Sickle Cell Disease

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sickle Cell Disease Infant, Newborn, Disease Drepanocytosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

newborn screening for sickle cell disease

Newborns with a targeted neonatal screening for sickle cell disease carried out at the University Hospital of Lyon

SCD newborn screening with the MS/MS method from Zentech

Intervention Type OTHER

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type OTHER