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NCT03985501: DREPAMASSE
DREPAMASSE Study - Evaluation of a Newborn Screening for Sickle Cell Disease by Tandem Mass Spectrometry
trial testing SCD newborn screening with the MS/MS method from Zentech in Sickle Cell Disease in 1,431 participants. Completed in 10 December 2022.
10 December 2022
Quick facts
| Lead sponsor | Hospices Civils de Lyon |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,431 |
| Start date | 16 March 2021 |
| Primary completion | 10 December 2022 |
| Estimated completion | 10 December 2022 |
| Sites | 3 locations across France |
Drugs / interventions tested
- SCD newborn screening with the MS/MS method from Zentech
Conditions studied
- Sickle Cell Disease — all drugs for Sickle Cell Disease →
- Infant, Newborn, Disease — all drugs for Infant, Newborn, Disease →
- Drepanocytosis — all drugs for Drepanocytosis →
Sponsor
Hospices Civils de Lyon — full company profile →
Who can join
Adults 1 Day to 27 Days, any sex, with Sickle Cell Disease or Infant, Newborn, Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Evaluation of a New Tandem Mass Spectrometry Method for Sickle Cell Disease Newborn Screening.
Renoux C, Roland E, Ruet S, Zouaghi S, et al · · 2024 · cited 1× · PMID 39728397 · DOI 10.3390/ijns10040077
Verify or expand the search:
- PubMed search for NCT03985501
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Sickle Cell Disease
Currently open trials in the same condition.
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- NCT06260891 — Zinc Supplementation in Sickle Cell Disease: A Precursor to the Think Zinc for Bones Trial · Phase 2 · recruiting
- NCT07222475 — Writing Relaxing Beats in Adolescents Who Have Sickle Cell Disease · NA · recruiting
- NCT07224360 — Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD) · Phase 2 · recruiting
Other Hospices Civils de Lyon trials
Trials by the same sponsor.
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- NCT07529314 — Evaluating Interventional Radiology for Cancer Pain Management · NA · not yet recruiting
- NCT07273929 — Comparative Study of the Effectiveness of Three Access Routes for Implanting an Electronic Intracardiac Device · Phase 3 · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03985501 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospices Civils de Lyon
- Last refreshed: 17 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03985501.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing