Determining Paediatric Usual Values for Hormones Dosages by Mass Spectrometry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,500
- Locations
- 1
- Primary Endpoint
- to determine paediatric usual values for hormones dosages by mass spectrometry
Study Overview
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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 20 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
to determine paediatric usual values for hormones dosages by mass spectrometry
Time Frame: 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)
Secondary Outcomes
No secondary outcomes reported