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

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ClinicalTrials.gov Identifier: NCT03985501
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : October 25, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief 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).


Condition or disease Intervention/treatment
Sickle Cell Disease Infant, Newborn, Disease Drepanocytosis Other: SCD newborn screening with the MS/MS method from Zentech

Study Design
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Study Type : Observational
Estimated Enrollment : 1440 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: DREPAMASSE Study - Evaluation of a Newborn Screening for Sickle Cell Disease by Tandem Mass Spectrometry
Actual Study Start Date : March 16, 2021
Estimated Primary Completion Date : September 16, 2023
Estimated Study Completion Date : September 16, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
newborn screening for sickle cell disease
Newborns with a targeted neonatal screening for sickle cell disease carried out at the University Hospital of Lyon
 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)


Outcome Measures
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Primary Outcome Measures :
  1. Percent agreement between the two techniques [ Time Frame: 6 months ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   up to 27 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants with SCD newborn screening conducted in the hospital center of Lyon
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985501


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

Locations
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France
Groupement Hospitalier Est - Hospices Civils de Lyon Recruiting
Bron, France, 69677
Contact: Céline RENOUX, MD, PhD    04.27.85.65.94 ext +33    celine.renoux@chu-lyon.fr   
Contact: David CHEILLAN, MD, PhD    04 72 12 96 88 ext +33    david.cheillan@chu-lyon.fr   
Principal Investigator: Céline RENOUX, MD, PhD         
Principal Investigator: GAUCHERAND PASCAL, MD, PhD         
Principal Investigator: Olivier CLARIS, PU, PH         
Centre Hospitalier Lyon Sud Recruiting
Pierre-Bénite, France, 69495
Contact: François GOLFIER, PU, PH         
Principal Investigator: GAVANIER DEBORAH, MD, PhD         
Principal Investigator: CLARIS OLIVIER, PU, PH         
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03985501    
Other Study ID Numbers: 69HCL19_0338
2019-A01346-51 ( Other Identifier: ID-RCB )
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Infant, Newborn, Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn