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

Launched by IRCCS AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA · Dec 3, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a condition called Central Precocious Puberty (CPP), where children start developing secondary sexual characteristics, like breast development or pubic hair, at an unusually early age. The study focuses on understanding how common this condition is, especially when it occurs without a known cause or alongside certain developmental disorders. Researchers will compare different characteristics of patients to better understand CPP.

To participate in the trial, children must be diagnosed with CPP and show signs like early development of sexual traits before age 8 for girls and 9 for boys. They should be between the ages of 2 and 18 years when they enroll, and their parents or guardians must give consent. Participants will be followed for at least a year, during which they can expect regular check-ups and assessments related to their condition. This study aims to gather important information to help improve diagnosis and treatment for children with CPP.

Gender

ALL

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.