Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children

NCT ID: NCT00438217

Last Updated: 2007-02-22

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Brief Summary

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The goal of CPP-EDG 01 study is to assess possible genetic and/or environmental parameters which may influence the growth rate of children affected by precocious puberty. In this view, we are collecting clinical data and biological samples of children attended as outpatients at the Pediatric Endocrine Center of Pisa from 1998 to present (the study is still open). From biological (blood) samples, gene polymorphisms such as endocrine disruptor levels are determined and compared to different growth pattern of pediatric patients treated with different GnRH agonists.

Detailed Description

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Conditions

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Central Precocious Puberty

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Triptorelin (GnRH agonists)

Intervention Type DRUG

Leuprolide (GnRH agonists)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinica diagnosis of central precocious puberty
* Diagnosis is based on growth spurt, bone age advancement, positive GnRH agonist stimulating test, pubertal sex steroid levels before 8 years of age for female and 9 years for male, respectively

Exclusion Criteria

* Thyroid disorders
* Peripheric diagnosis of precocious puberty
* Genetic disorders
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pisa

OTHER

Sponsor Role lead

Principal Investigators

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Giuseppe Saggese, MD

Role: STUDY_DIRECTOR

Department of Pediatrics, University of Pisa

Locations

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Center of Pediatric endocrinology, Department of Pediatrics, University of Pisa

Pisa, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Francesco Massart, MD, PhD

Role: CONTACT

0039 050 99 3600 ext. 2950

Facility Contacts

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Francesco Massart, MD, PhD

Role: primary

+39-050-99-3600 ext. 2950

Other Identifiers

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CPP-EDG 01

Identifier Type: -

Identifier Source: org_study_id

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