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

ConditionControl Condition

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

AgeUp to 20

SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Male or female patient ≤ 20 years old

undergoing a blood sample as part of their pathology routine follow-up

Disqualifiers

Any identified or suspected endocrine pathology

Any acute infectious or inflammatory disorder

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,500 Participants

are grouped into 1 trial group

Group A: Control individuals below 20 years of age

Trial outcomes

Primary outcomes

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)

Time frame

1 week

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov

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