Idiopathic Central Precocious Puberty and Associated Neurodevelopmental Syndromes and Pathologies: Evaluation of Frequency and Comparison of Diagnostic and Developmental Characteristics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Frequency of diagnosis of idiopathic or syndromic Central Precocious Puberty
研究概览
简要总结
Observational, retrosopective, single-centre, non-profit study focused on the frequency of Central Precocious Puberty idiopathic, or associated to Neurodevelopmental Syndromes and Pathologies, and comparison of diagnostic and developmental characteristics of patients.
详细描述
The study enrolls both male and female patients referred to the Pediatrics Unit of the IRCCS Azienda Ospedaliero-Universitaria Policlinico di Sant'Orsola between 01/01/2013 and 31/12/2023 for Central Precocious Puberty and treated with GnRH analouge. The primary aim of the study is to Assess the frequency of diagnosis of idiopathic or syndromic Central Precocious Puberty in the last decade. The secondary aims are to Compare clinical, laboratory and instrumental characteristics at diagnosis and in follow-up between patients with idiopathic and syndromic PPC, and to identifying possible pathogenetic factors characterising different forms of Central Precocious Puberty.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Central Precocious Puberty presenting an indication to undertake treatment with GnRH analogue: Appearance of secondary sexual characteristics (thelarche or gonadarche) before the age of 8 for females and 9 for males; Acceleration of the rate of statural growth and advancement of bone age one year older than the chronological age; LH peak > 5 IU/L on GnRH test and a longitudinal uterine diameter > 36 mm in females, with or without the appearance of endometrial rhyme;
- •Age at onset of entral Precocious Puberty between 2 and 8 years (females) or between 2 and 9 years (males);
- •Age at enrollment < 18 years;
- •Follow-up of at least 12 months;
- •Obtaining informed consent from parents/legal guardian of peduatric patients.
排除标准
- •Isolated telarche and/or pubarche;
- •Peripheral forms of precocious puberty;
- •Patients diagnosed with primary organic Central Precocious Puberty due to tumour- or non-tumour-causing hypothalamic lesions.
结局指标
主要结局
Frequency of diagnosis of idiopathic or syndromic Central Precocious Puberty
时间窗: at baseline
diagnosis of idiopathic or syndromic Central Precocious Puberty
次要结局
未报告次要终点
研究者
Federico Baronio
MD
IRCCS Azienda Ospedaliero-Universitaria di Bologna