Clinical trial NCT06263868: First Observatory of Precocious Puberty.
Official title: First Observatory of Precocious and Advanced Puberty in Private Healthcare.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Puberty, Precocious
Keywords: Early/precocious puberty
advanced puberty
national observatory
private medicine
feasibility
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 3360
Sex: ALL
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited in private heathlcare: 2880 patients distributed between the 2 following groups: PP (Precocious puberty group) and PA (Advanced puberty group), and 480 children in the control group.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of recruited patients with at least 80% of the main data collected
timeFrame: Up to 48 month
measure: Missing data rate
timeFrame: Up to 48 month
measure: At least 75% of patients included
timeFrame: Up to 48 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ecully
country: France
facility: Clinique du Val d'Ouest
state: Auvergne-Rhône-Alpes
city: Ecully
country: France
facility: Clinique du Val d'Ouest
state: Auvergne-Rhône-Alpes
city: Ecully
country: France
facility: Clinique du Val d'Ouest
state: Auvergne-Rhône-Alpes
city: Lyon
country: France
facility: Pediatric practice
state: Auvergne-Rhône-Alpes
city: Rennes
country: France
facility: Pediatric practice
state: Bretagne
city: Chambray-lès-Tours
country: France
facility: Pediatric practice
state: Centre-Val de Loire
city: Essey-lès-Nancy
country: France
facility: Pediatric practice
state: Grand Est
city: Levallois-Perret
country: France
facility: Pediatric practice
state: Hauts-de-Seine
city: Paris
country: France
facility: Pediatric practice
state: Ile-de-France
city: Fondettes
country: France
facility: Pediatric practice
state: Indre-et-Loire
city: Lormont
country: France
facility: Polyclinique Bordeaux rive droite
state: Nouvelle-Aquitaine
city: Pau
country: France
facility: Pediatric practice
state: Nouvelle-Aquitaine
city: Pessac
country: France
facility: Pediatric Practice
state: Nouvelle-Aquitaine
city: Toulouse
country: France
facility: Clinique rive gauche
state: Occitanie
city: Saint-Nazaire
country: France
facility: Pediatric practice
state: Pays de la Loire
city: Aix-en-Provence
country: France
facility: Pediatric practice
city: Bron
country: France
facility: Hôpital Femme Mère Enfant, Hospices civils de Lyon
city: Marseille
country: France
facility: Pediatric practice
city: Marseille
country: France
facility: Pediatric practice
city: Nice
country: France
facility: Pediatric practice
city: Saint Jean de Vedas
country: France
facility: Clinique Saint jean
city: Trélazé
country: France
facility: Pediatric practice
city: Paris
country: France
facility: Pediatric practice
state: Île-De-France
city: Paris
country: France
facility: Pediatric practice
state: Île-De-France
city: Paris
country: France
facility: Pediatric practice
state: Île-De-France
Study officials:
affiliation: Hospices Civils de Lyon
name: Emillie DOYE, MD
role: PRINCIPAL_INVESTIGATOR
References: