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

Determining Paediatric Usual Values for Hormones Dosages by Mass Spectrometry

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.

Study Overview

• Status: Recruiting
• Conditions: Control Condition

Detailed Description

This is a prospective, multicentric, non-randomized. The study will be uncontrolled, as it will use subjects considered "healthy" to establish reference values.

Recruitment is planned to take place in hospital consultations at recruiting centers belonging to the AP-HP.

During the blood sample prescribed as part of the follow-up consultation, an additional blood tube will be collected after information, consent and inclusion.

The following acts and procedures will be added as part of the research:

• additional tube, respecting the total volume taken according to weight (maximum volume of 2.7mL);
• Routine circuit for sending and receiving the tube to ensure the relevance of standards established in real life.
• A biological collection will be set up. Pseudonymized data will be collected on a secure REDCap database. The source data will be: Recruiting center; Age; Gender; Pubertal stage if available; Results of blood tests carried out by mass spectrometry as part of this research.

The clinical database will be completed by investigators from the Endocrine Functional Explorations Department at Trousseau Hospital and biologists from the METOMICS Department at Saint-Antoine Hospital. Data will not be processed outside the AP-HP. Data will be kept in an active secured database for the duration of the study and up to 2 years after the last publication, and archived for 15 years.

Mass spectrometry analyses will be carried out under the supervision of Pr Antonin Lamazière, Head of the Clinical Metabolomics Department at Hôpital Saint Antoine. Data from these analyses will be stored in the same clinical laboratory and shared only with/between the principal investigator and the study methodologist.

During the research phase, the collection will be stored at the Clinical Metabolomics Department (METOMICS) laboratory, under the responsibility of Prof. Antonin Lamazière, for 2 years. At the end of the research, the samples will be stored for a maximum of 15 years.

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Eloïse Giabicani, MD, PhD; Phone Number: +33 (0)1 49 28 66 94; Email: eloise.giabicani@aphp.fr
• Study Contact Backup: Name: Marie-Pierre LUTON, PhD; Phone Number: +33(0) 1 87 89 26 00; Email: mariepierre.luton@aphp.fr

Study Locations

• France
  • Paris
    • Paris, Paris, France, 75012
      • Recruiting
      • Service d'Endocrinologie Pédiatrique-Explorations Fonctionnelles Hôpital Trousseau
      • Contact: Eloïse Giabicani, MD, PhD; Phone Number: +33 (0)1 49 28 66 94; Email: eloise.giabicani@aphp.fr
      • Contact: Marie-Pierre LUTON, PhD; Phone Number: +33(0) 1 87 89 26 00; Email: mariepierre.luton@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Control individuals below 20 years of age; blood sample with hormone dosages

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Actual): November 19, 2024

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Children; LC-MS/MS; Hormones; Usual values
• Other Study ID Numbers: APHP240887; IDRCB-2024-A01634-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No