First Observatory of Precocious Puberty.

Официальное название

First Observatory of Precocious and Advanced Puberty in Private Healthcare.

Обзор

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.

Первичные конечные точки

• Number of recruited patients with at least 80% of the main data collected [Срок оценки: Up to 48 month]
• Missing data rate [Срок оценки: Up to 48 month]
• At least 75% of patients included [Срок оценки: Up to 48 month]

Критерии участия

Критерии включения

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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Франция · 25 центров

• 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
• … и ещё 17 центров

Идентификаторы

NCT: NCT06263868 · 69HCL23_1090 · 2023-A02313-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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