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

NCT06694415 | Recruiting

• 2 other identifiers: APHP240887IDRCB-2024-A01634-43
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

LC-MS/MS; Hormones; Children; Usual values

Outcome Measures

Primary Outcomes (1)

• to determine paediatric usual values for hormones dosages by mass spectrometry

  internal quality control (IQC) suitability/match between the one provided by the manufacturer or developed in-house, and inter-laboratory comparisons (EQA/EIL)

  1 week

Study Arms (1)

Control individuals below 20 years of age

blood sample with hormone dosages

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients followed in paediatrics from birth to 20 years undergoing a blood sample as part of their pathology routine follow-up in one of the identified recruiting centers (see below). Patients with no identified or suspected endocrine pathology or no infectious or inflammatory disorder.

You may qualify if:

• Male or female patient ≤ 20 years old
• undergoing a blood sample as part of their pathology routine follow-up

You may not qualify if:

• Any identified or suspected endocrine pathology
• Any acute infectious or inflammatory disorder

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service d'Endocrinologie Pédiatrique-Explorations Fonctionnelles Hôpital Trousseau

Paris, Paris, 75012, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum frozen storage

Study Officials

• Eloïse Giabicani, MD, PhD

  Organizational Affiliation: Assistance Publique - Hôpitaux de Paris (AP-HP en général)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eloïse Giabicani, MD, PhD

CONTACT

+33 (0)1 49 28 66 94; eloise.giabicani@aphp.fr

Marie-Pierre Luton, PhD

CONTACT

+33(0) 1 87 89 26 00; mariepierre.luton@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: January 2, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

FR (1)