Actively Recruiting

Age: 0 - 20Years
All Genders
Healthy Volunteers
ID06694415

Determining Pediatric Usual Hormone Values Using Mass Spectrometry

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-08-26

1500

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a study to establish usual hormone level values in children and adolescents up to 20 years old using liquid chromatography coupled with mass spectrometry (LC-MS/MS). This method allows for precise hormone measurements from small blood samples and aims to improve upon older immunoassay techniques that have limitations and safety concerns. The study is prospective, multicenter, and observational, focusing on healthy individuals without endocrine or acute inflammatory conditions. Participants will have an additional blood sample taken during a routine follow-up blood draw at hospital consultations within the Assistance Publique - Hôpitaux de Paris network. The extra blood volume will be carefully limited based on weight, with a maximum of 2.7 mL collected. The samples will be analyzed by mass spectrometry at specialized clinical metabolomics laboratories under expert supervision. During the study, securely pseudonymized data including age, gender, pubertal stage, and hormone test results will be recorded in a confidential database. Samples and data will be stored securely for up to 15 years following the research phase. The primary goal is to determine normal hormone values in the pediatric population over a one-week measurement period. This research will help improve hormone assay reliability and patient management in clinical practice.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 20Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patient 20 years old or younger
  • Undergoing a blood sample as part of their routine health follow-up
Not Eligible

You will not qualify if you...

  • Any identified or suspected endocrine disorder
  • Any acute infectious or inflammatory condition

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) during routine health follow-up

Sample Collection

Duration - 1 week

Participants undergo an additional blood sample collection during their routine health follow-up to measure hormone dosages using mass spectrometry.

1 visit (in-person) coinciding with routine blood sample collection

Long-term Monitoring

Duration - Up to 15 years

Participant samples and data are stored securely for research and reference value establishment over several years.

No additional visits required

Trial Site Locations

Total: 1 location

1

Service d'Endocrinologie Pédiatrique-Explorations Fonctionnelles Hôpital Trousseau

Paris, Paris, France, 75012

Actively Recruiting

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Research Team

E

Eloïse Giabicani, MD, PhD

M

Marie-Pierre Luton, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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