DREPAMASSE Study - Evaluation of a Newborn Screening for Sickle Cell Disease by Tandem Mass Spectrometry (DREPAMASSE)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03985501 |
|
Recruitment Status :
Recruiting
First Posted : June 13, 2019
Last Update Posted : March 22, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 Type : | Observational |
| Estimated Enrollment : | 1040 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 : | March 16, 2022 |
| Estimated Study Completion Date : | March 16, 2022 |
| 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) |
- 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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | up 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 | Not yet 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: Muriel DORET-DION, MD, PhD | |
| Principal Investigator: Olivier CLARIS, PU, PH | |
| Hôpital de la Croix Rousse | Not yet recruiting |
| Lyon, France, 69317 | |
| Contact: Cyril HUISSOUD, PU, PH | |
| Contact: Jean-Charles PICAUD, PU, PH | |
| Principal Investigator: Cyril HUISSOUD, PU, PH | |
| Principal Investigator: Jean-Charles PICAUD, PU, PH | |
| Centre Hospitalier Lyon Sud | Recruiting |
| Pierre-Bénite, France, 69495 | |
| Contact: François GOLFIER, PU, PH | |
| Principal Investigator: François GOLFIER, PU, PH | |
| 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: | March 22, 2021 |
| Last Verified: | March 2021 |
| 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 |