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Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children (CPP-EDG 01)

Primary Purpose

Central Precocious Puberty

Status

Unknown status

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Triptorelin (GnRH agonists)

Leuprolide (GnRH agonists)

About this trial

This is an interventional prevention trial for Central Precocious Puberty focused on measuring precocious puberty, genetics, environmental factors

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00438217

First Posted

February 21, 2007

Last Updated

February 21, 2007

Sponsor

University of Pisa

1. Study Identification

Unique Protocol Identification Number

NCT00438217

Brief Title

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

Acronym

CPP-EDG 01

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2007

Overall Recruitment Status

Unknown status

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

University of Pisa

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Precocious Puberty

Keywords

precocious puberty, genetics, environmental factors

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Triptorelin (GnRH agonists)

Intervention Type

Drug

Intervention Name(s)

Leuprolide (GnRH agonists)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Francesco Massart, MD, PhD

Phone

0039 050 99 3600

Ext

2950

massart@med.unipi.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giuseppe Saggese, MD

Organizational Affiliation

Department of Pediatrics, University of Pisa

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Pisa

ZIP/Postal Code

56125

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Francesco Massart, MD, PhD

Phone

+39-050-99-3600

Ext

2950

massart@med.unipi.it

12. IPD Sharing Statement

Learn more about this trial

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

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