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

NCT06720844 | Recruiting

• 1 other identifier: SDR-PPC23
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Precocious Puberty (CPP)

Keywords

Central Precocious Puberty

Outcome Measures

Primary Outcomes (1)

• Frequency of diagnosis of idiopathic or syndromic Central Precocious Puberty

  diagnosis of idiopathic or syndromic Central Precocious Puberty

  at baseline

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bolgona, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Puberty, Precocious

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Officials

• Federico Baronio, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Baronio, MD

CONTACT

00390512144816; federico.baronio@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: March 13, 2024
• Primary Completion (Estimated): March 13, 2027
• Study Completion (Estimated): May 13, 2027
• Last Updated: March 12, 2026

Record last verified: 2025-12

Locations

IT (1)