Normal hormone levels in children measured by LC‑MS/MS
Determining Paediatric Usual Values for Hormones Dosages by Mass Spectrometry
Assistance Publique - Hôpitaux de Paris · NCT06694415
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 |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | N/A to 20 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Paris, Paris) |
| Trial ID | NCT06694415 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Paris, Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Control Condition, LC-MS/MS, Hormones, Children, Usual values