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出境医 / 临床实验 / DREPAMASSE Study - Evaluation of a Newborn Screening for Sickle Cell Disease by Tandem Mass Spectrometry (DREPAMASSE)
DREPAMASSE Study - Evaluation of a Newborn Screening for Sickle Cell Disease by Tandem Mass Spectrometry (DREPAMASSE)
Study Description
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
| 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 |
Arms and Interventions
| 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
Primary Outcome Measures :
- 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
| 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
Contacts
| 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
| 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 | |
Sponsors and Collaborators
Hospices Civils de Lyon
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 6, 2019 | ||||||||
| First Posted Date | June 13, 2019 | ||||||||
| Last Update Posted Date | March 22, 2021 | ||||||||
| Actual Study Start Date | March 16, 2021 | ||||||||
| Estimated Primary Completion Date | March 16, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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)
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | DREPAMASSE Study - Evaluation of a Newborn Screening for Sickle Cell Disease by Tandem Mass Spectrometry | ||||||||
| Official Title | DREPAMASSE Study - Evaluation of a Newborn Screening for Sickle Cell Disease by Tandem Mass Spectrometry | ||||||||
| 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). |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Infants with SCD newborn screening conducted in the hospital center of Lyon | ||||||||
| Condition |
|
||||||||
| Intervention | 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)
|
||||||||
| Study Groups/Cohorts | newborn screening for sickle cell disease
Newborns with a targeted neonatal screening for sickle cell disease carried out at the University Hospital of Lyon
Intervention: Other: SCD newborn screening with the MS/MS method from Zentech
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
1040 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | March 16, 2022 | ||||||||
| Estimated Primary Completion Date | March 16, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender |
|
||||||||
| Ages | up to 27 Days (Child) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
|
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| Listed Location Countries | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03985501 | ||||||||
| Other Study ID Numbers | 69HCL19_0338 2019-A01346-51 ( Other Identifier: ID-RCB ) |
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| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Hospices Civils de Lyon | ||||||||
| Study Sponsor | Hospices Civils de Lyon | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | Hospices Civils de Lyon | ||||||||
| Verification Date | March 2021 | ||||||||
