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 : July 28, 2022
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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 |
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Sickle Cell Disease Infant, Newborn, Disease Drepanocytosis | Other: SCD newborn screening with the MS/MS method from Zentech |
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 |

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

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Ages Eligible for Study: | 1 Day to 27 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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
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 |
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: PASCAL GAUCHERAND, MD, PhD | |
Principal Investigator: Giovannia CANNAS | |
Hopital de la Croix Rousse | Not yet recruiting |
Lyon, France, 69004, | |
Contact: Fanny ROUMIEU, MD,PhD 04.26.73.25.53 ext +33 fanny.roumieu@chu-lyon.fr | |
Principal Investigator: Fanny ROUMIEU, MD,PhD | |
Centre Hospitalier Lyon Sud | Recruiting |
Pierre-Bénite, France, 69495 | |
Contact: François GOLFIER, PU, PH | |
Principal Investigator: GAVANIER DEBORAH, MD, PhD |
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: | July 28, 2022 |
Last Verified: | July 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Anemia, Sickle Cell Infant, Newborn, Diseases Anemia, Hemolytic, Congenital Anemia, Hemolytic |
Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |