Idiopathic Central Precocious Puberty and Associated Neurodevelopmental Syndromes and Pathologies: Evaluation of Frequency and Comparison of Diagnostic and Developmental Characteristics
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: Central Precocious Puberty (CPP). Basic parameters: up to 18 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
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Primary outcome measures
- Frequency of diagnosis of idiopathic or syndromic Central Precocious Puberty [Time frame: at baseline]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06720844 · SDR-PPC23