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Recruiting Observational

Determining Paediatric Usual Values for Hormones Dosages by LC-MS/MS

NCT06694415 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-01-02
Last updated
2025-08-26

Condition(s) studied

Control Condition

Study summary

Liquid chromatography coupled with mass spectrometry (LC-MS/MS) is now the method of choice for steroid hormone analysis, as it enables analyses to be carried out on small-volume samples on a wider range of hormones, with improved specificity compared with immunoassays. Hormone assays currently face a twofold problem: on the one hand, immunoassays are highly dependent on the synthesis of antibody kits manufactured by companies with immunotechnology expertise; on the other hand, these immunoassays may require the use of radioactive products for quantification, generating considerable risks for both staff and environment. There are international recommendations from expert societies (World Anti-Doping Agency, Endocrine society) to develop new, more reliable assay methods, such as LC-MS/MS, and to phase out immuno- and radioassay techniques.

However, changing measurement methods requires the development of reference values to maintain and optimize the management of patients.

The aim of this project is therefore to establish usual values in a paediatric population, through collaboration between the clinical departments of the APHP and the METOMICS laboratory, which has mastered the technology.

Eligibility

Sex
ALL
Min age
—
Max age
20 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Male or female patient ≤ 20 years old * undergoing a blood sample as part of their pathology routine follow-up Exclusion Criteria: * Any identified or suspected endocrine pathology * Any acute infectious or inflammatory disorder

Primary outcome measure(s)

  • to determine paediatric usual values for hormones dosages by mass spectrometry — 1 week
    internal quality control (IQC) suitability/match between the one provided by the manufacturer or developed in-house, and inter-laboratory comparisons (EQA/EIL)

Trial sites (1)

FacilityCityRegionStatus
Service d'Endocrinologie Pédiatrique-Explorations Fonctionnelles Hôpital Trousseau Paris Paris Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06694415 on ClinicalTrials.gov ↗ ← All trials in France