First Observatory of Precocious Puberty.

Recruiting

• Conditions: Puberty, Precocious

• Registration Number: NCT06263868
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

The age of puberty has fluctuated throughout history. Recent data shows an increase in the age of onset of puberty signs, in the United States but also in Europe. A recent Public Health France study published in 2018 reports an increase in the incidence of precocious puberty with geographical heterogeneity. The consequences of these appearances include the early onset of menarche, short adult height and the psychological impact.

Due to a lack of studies and additional data, the reasons for this development are difficult to understand. Among current hypotheses, the entanglement with the evolution of our environment is at the forefront: the action of environmental endocrine disruptors and nutritional factors could play a role in the process of early appearance of pubertal signs.

The establishment of a national observatory for early and advanced puberty in collaboration with pediatric endocrinologists (on the front line) would allow a reliable and precise field approach, capable of supplementing epidemiological data, which are currently insufficient.

The investigators hypothesize that the establishment of an observatory of pubertal advances (early puberty and advanced puberty) in private medicine is possible, with inclusion of at least 75% of eligible patients, and collection of at least 80% of data.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-09
• Study First Submitted QC: 2024-02-09
• Study First Posted: 2024-02-16
• Study Start: 2024-06-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-10
• Primary Completion: 2028-06-26
• Study Completion: 2028-06-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3360

Inclusion Criteria

Precocious puberty group (PP) :

• Suspected precocious puberty (girl aged < 8 years or boy aged < 9 years when the first signs of development* appear)
• Suspected precocious puberty (girl aged < 8 years or boy aged < 9 years when the first signs of development* appear)

Advanced puberty group (AP) :

• Suspected advanced puberty (girl aged ≥ 8 and < 10 years or boy aged ≥ 9 and < 11 years when the first signs of development* appear)
• First consultation with the investigator (pediatric endocrinologist).

Control group :

• Boy or girl without signs of pubertal development (Tanner 1);
• Matched to the PP group on sex and age (+/- 1 year);
• Consultation with the same investigator over the same period (same quarter) as a patient in the PP group

Exclusion Criteria

All groups

• Consultation with the same investigator over the same period (same quarter) as a patient in the PP group
• Family not speaking French, language barrier.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of recruited patients with at least 80% of the main data collected	Up to 48 month	Number of recruited patients with at least 80% of the main data collected (weight, height, BMI, pubertal stage, date of onset of pubertal signs, questionnaires).
Missing data rate	Up to 48 month	Missing data rate less than 10% for pubertal stage.
At least 75% of patients included	Up to 48 month	At least 75% of patients included compared to the number of eligible patients.

Trial Locations

Locations (7)

Clinique du Val d'Ouest; 🇫🇷 Ecully, Auvergne-Rhône-Alpes, France

Clinique rive gauche; 🇫🇷 Toulouse, Occitanie, France

Pediatric practice; 🇫🇷 Paris, Île-De-France, France

Polyclinique Bordeaux rive droite; 🇫🇷 Lormont, Nouvelle-Aquitaine, France

Pediatric Practice; 🇫🇷 Pessac, Nouvelle-Aquitaine, France

Hôpital Femme Mère Enfant, Hospices civils de Lyon; 🇫🇷 Bron, France

Clinique Saint jean; 🇫🇷 Saint Jean de Vedas, France