Normal hormone levels in children measured by LC‑MS/MS
Official title: Determining Paediatric Usual Values for Hormones Dosages by Mass Spectrometry
Run by Assistance Publique - Hôpitaux de Paris · NCT06694415 · Data updated 2026-11-12
This project will try LC‑MS/MS hormone testing on blood samples from kids and young people (up to 20 years) to create normal reference values.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 20 Years |
| Sex | All |
| Enrollment | 1500 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, Paris) |
| Status | Recruiting |
| Started | January 2, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | August 26, 2025 |
| Trial ID | NCT06694415 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Kids and young people aged 20 years or younger who are undergoing a routine blood draw, are clinically well without known or suspected endocrine disease, and have no acute infection or inflammatory disorder are ideal candidates.
✕Probably not a fit
Patients with known or suspected endocrine disorders, or those with acute infectious or inflammatory conditions, are excluded and will not benefit from this reference-value collection.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multicenter, non-randomized observational project using children and young people considered healthy to establish reference hormone values by LC‑MS/MS. An extra small blood tube (within safe volume limits) will be collected during routine clinic blood draws at participating AP‑HP pediatric endocrinology centers. Samples will be pseudonymized and entered into a secure REDCap database, and mass spectrometry analyses will be performed within the AP‑HP network under expert supervision. The resulting data will be used to produce pediatric reference ranges to support clinical interpretation when switching from immunoassays to LC‑MS/MS.
Why it matters
Potential benefit: If successful, clinicians will have more accurate and specific pediatric hormone reference ranges that can improve diagnosis and treatment decisions while reducing reliance on less-specific immunoassays.
How similar studies have gone: LC‑MS/MS is widely adopted and prior work has successfully produced adult and some pediatric reference data, though comprehensive multicenter pediatric norms remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Service d'Endocrinologie Pédiatrique-Explorations Fonctionnelles Hôpital Trousseau
Paris, Paris, France Recruiting
Study contacts
- Principal investigator: Eloïse Giabicani, MD, PhD — Organizational Affiliation: Assistance Publique - Hôpitaux de Paris (AP-HP en général)
- Study coordinator: Eloïse Giabicani, MD, PhD
- Email: eloise.giabicani@aphp.fr
- Phone: +33 (0)1 49 28 66 94
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.