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

NCT ID: NCT06720844

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-13

Study Completion Date

2025-05-13

Brief Summary

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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

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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.

Conditions

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Central Precocious Puberty (CPP)

Keywords

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Central Precocious Puberty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Federico Baronio, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bolgona, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Federico Baronio, MD

Role: CONTACT

Phone: 00390512144816

Email: [email protected]

Facility Contacts

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Federico Baronio

Role: primary

Federico Baronio

Role: backup

Other Identifiers

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SDR-PPC23

Identifier Type: -

Identifier Source: org_study_id