Evaluation of Central Precocious Puberty and Related Neurodevelopmental Conditions

Idiopathic Central Precocious Puberty and Associated Neurodevelopmental Syndromes and Pathologies: Evaluation of Frequency and Comparison of Diagnostic and Developmental Characteristics

This study looks at how often kids are diagnosed with Central Precocious Puberty and whether it’s linked to other developmental conditions.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: N/A to 18 Years
• Sex: All
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna (other)
• Locations: 1 site (Bologna, Bolgona)
• Trial ID: NCT06720844 on ClinicalTrials.gov

What this trial studies

This observational study focuses on the frequency of idiopathic Central Precocious Puberty (CPP) and its association with neurodevelopmental syndromes. It involves a retrospective analysis of patients referred to the Pediatrics Unit of the IRCCS Azienda Ospedaliero-Universitaria Policlinico di Sant'Orsola from 2013 to 2023. The primary aim is to assess the frequency of CPP diagnoses, while secondary aims include comparing clinical and laboratory characteristics between idiopathic and syndromic cases and identifying potential pathogenetic factors. The study includes both male and female patients treated with GnRH analogues.

Who should consider this trial

Good fit: Ideal candidates are children diagnosed with Central Precocious Puberty who are under 18 years old and have been referred for treatment with GnRH analogues.

Not a fit: Patients with isolated telarche or pubarche, peripheral forms of precocious puberty, or primary organic CPP due to tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of Central Precocious Puberty and improve diagnostic and treatment approaches for affected patients.

How similar studies have performed: While there have been studies on Central Precocious Puberty, this specific observational approach focusing on idiopathic cases and neurodevelopmental associations is relatively novel.

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.

Where this trial is running

Bologna, Bolgona

• IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bolgona, Italy (RECRUITING)

Study contacts

• Principal investigator: Federico Baronio, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Study coordinator: Federico Baronio, MD

Conditions: Central Precocious Puberty