First Observatory of Precocious Puberty.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Puberty, Precocious. Basic parameters: up to 11 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
First Observatory of Precocious and Advanced Puberty in Private Healthcare.
Overview
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.
Primary outcome measures
- Number of recruited patients with at least 80% of the main data collected [Time frame: Up to 48 month]
- Missing data rate [Time frame: Up to 48 month]
- At least 75% of patients included [Time frame: Up to 48 month]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
France · 25 centers
- Clinique du Val d'Ouest — Écully
- Clinique du Val d'Ouest — Écully
- Clinique du Val d'Ouest — Écully
- Pediatric practice — Lyon
- Pediatric practice — Rennes
- Pediatric practice — Chambray-lès-Tours
- Pediatric practice — Essey-lès-Nancy
- Pediatric practice — Levallois-Perret
- … and 17 more centers
Identifiers
NCT: NCT06263868 · 69HCL23_1090 · 2023-A02313-42