Clinical trial NCT06720844: Idiopathic Central Precocious Puberty and Associated Neurodevelopmental Syndromes and Pathologies: Evaluation of Frequency and Comparison of Diagnostic and Developmental Characteristics
Official title: Idiopathic Central Precocious Puberty and Associated Neurodevelopmental Syndromes and Pathologies: Evaluation of Frequency and Comparison of Diagnostic and Developmental Characteristics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Central Precocious Puberty (CPP)
Keywords: Central Precocious Puberty
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 300
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All 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.

Brief summary: 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.

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.

Primary outcomes:
measure: Frequency of diagnosis of idiopathic or syndromic Central Precocious Puberty
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
state: Bolgona
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Federico Baronio, MD
role: PRINCIPAL_INVESTIGATOR
References: