First Observatory of Precocious Puberty.

Puberty, Precocious Clinical Trial

— PAPPEL  

Official title:

First Observatory of Precocious and Advanced Puberty in Private Healthcare.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06263868
• Other study ID #: 69HCL23_1090
• Secondary ID: 2023-A02313-42
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: March 1, 2028

Study information

• Verified date: February 2024
• Source: Hospices Civils de Lyon
• Contact: Emillie Doye, MD
• Phone: 0472118890
• Email: emilie.doye[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3360
• Est. completion date: March 1, 2028
• Est. primary completion date: March 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Puberty, Precocious

Locations

Country	Name	City	State
France	Pediatric practice	Aix-en-Provence	Provence-Alpes-Côte d'Azur
France	Hôpital Femme Mère Enfant, Hospices civils de Lyon	Bron
France	Pediatric practice	Chambray-lès-Tours	Centre-Val De Loire
France	Clinique du Val d'Ouest	Ecully	Auvergne-Rhône-Alpes
France	Clinique du Val d'Ouest	Ecully	Auvergne-Rhône-Alpes
France	Clinique du Val d'Ouest	Ecully	Auvergne-Rhône-Alpes
France	Pediatric practice	Essey-lès-Nancy	Grand Est
France	Pediatric practice	Fondettes	Indre-et-Loire
France	Pediatric practice	Levallois-Perret	Hauts-de-Seine
France	Polyclinique Bordeaux rive droite	Lormont	Nouvelle-Aquitaine
France	Clinique Saint jean	Lyon	Auvergne-Rhône-Alpes
France	Pediatric practice	Lyon	Auvergne-Rhône-Alpes
France	Pediatric practice	Marseille	Provence-Alpes-Côte d'Azur
France	Pediatric practice	Marseille	Provence-Alpes-Côte-d'Azur
France	Pediatric practice	Nice	Provence-Alpes-Côte d'Azur
France	Pediatric practice	Paris	Île-De-France
France	Pediatric practice	Paris	Île-De-France
France	Pediatric practice	Paris	Île-De-France
France	Pediatric practice	Paris	Ile-de-France
France	Pediatric practice	Pau	Nouvelle-Aquitaine
France	Pediatric Practice	Pessac	Nouvelle-Aquitaine
France	Pediatric practice	Rennes	Bretagne
France	Pediatric practice	Saint-Nazaire	Pays De La Loire
France	Clinique rive gauche	Toulouse	Occitanie
France	Pediatric practice	Trélazé	Pays De La Loire

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of recruited patients with at least 80% of the main data collected	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).	Up to 48 month
Primary	Missing data rate	Missing data rate less than 10% for pubertal stage.	Up to 48 month
Primary	At least 75% of patients included	At least 75% of patients included compared to the number of eligible patients.	Up to 48 month