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

NCT06694415 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2025-08-26

No results posted yet for this 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.

Conditions

  • Control Condition

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Eloïse Giabicani, MD, PhD · Organizational Affiliation: Assistance Publique - Hôpitaux de Paris (AP-HP en général)

Eligibility

Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-02
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06694415 on ClinicalTrials.gov