- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00438217
Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children (CPP-EDG 01)
February 21, 2007 updated by: University of Pisa
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Francesco Massart, MD, PhD
- Phone Number: 2950 0039 050 99 3600
- Email: massart@med.unipi.it
Study Locations
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-
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Pisa, Italy, 56125
- Recruiting
- Center of Pediatric endocrinology, Department of Pediatrics, University of Pisa
-
Contact:
- Francesco Massart, MD, PhD
- Phone Number: 2950 +39-050-99-3600
- Email: massart@med.unipi.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Giuseppe Saggese, MD, Department of Pediatrics, University of Pisa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
February 21, 2007
First Submitted That Met QC Criteria
February 21, 2007
First Posted (Estimate)
February 22, 2007
Study Record Updates
Last Update Posted (Estimate)
February 22, 2007
Last Update Submitted That Met QC Criteria
February 21, 2007
Last Verified
February 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Gonadal Disorders
- Puberty, Precocious
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Fertility Agents, Female
- Fertility Agents
- Luteolytic Agents
- Leuprolide
- Triptorelin Pamoate
- Prolactin Release-Inhibiting Factors
Other Study ID Numbers
- CPP-EDG 01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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