Evaluation of Central Precocious Puberty and Related Neurodevelopmental Conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: federico.baronio@aosp.bo.it
• Phone: 00390512144816

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Basal LH threshold for diagnosing central precocious puberty

  This study tests whether a single, baseline LH measurement can correctly diagnose central precocious puberty in kids and reduce the need for the LHRH stimulation test.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07864116

• INSL3 as a Biomarker to See If Puberty Has Started

  Researchers are testing whether a single blood test for INSL3 can tell if a child’s puberty has begun, potentially reducing need for the GnRH stimulation test.

  Recruiting IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna · NCT07859787

• Leuprorelin 1-Month in Children with Central Precocious Puberty

  This study tests whether a 1-month formulation of leuprorelin can safely manage central precocious puberty in children over 24 months.

  Recruiting Phase 4 LG Chem · Seoul · NCT07710430

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.