- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00710307
Epidemiology Study on Insulin-like Growth Factor-1 in Children With Idiopathic Short Stature (EPIGROW Study) (EPIGROW)
January 11, 2019 updated by: Ipsen
Descriptive, Cross-sectional and Prospective Epidemiology Study, on the Identification of Insulin-like Growth Factor-1 Status in Idiopathic Short Stature Children (EPIGROW Study)
The purpose of the protocol is to describe the distribution of IGF-1 deficiency in the studied population of Idiopathic Short Children without Growth Hormone Deficiency or any other identified cause of short stature and not treated with recombinant Growth Hormone or IGF-1
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
275
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France
- Ipsen Central Contact
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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
2 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Idiopathic Short Stature children
Description
Inclusion Criteria:
- Short children, height ≤ -2.5 SDS
- Age ≥ 2 years
- With at least one normal or elevated peak GH response to a stimulatory test (peak GH ≥ 7 ng/mL) at the time of the study and/or at a given time-point during the last 12 months
- Pre-pubertal
- Signed Informed Consent, including agreement to have blood samples taken for hormonal measurement and genetic analysis, by both parents or by Legally Acceptable Representatives when applicable and the child when applicable
Exclusion Criteria:
- The following identified causes of short stature:
- GH-deficient short stature
- Other endocrine causes (hypothyroidism, Cushing's syndrome, parathyroid or vitamin D disorders, hypogonadism)
- Identified syndromes with genetic abnormalities (including Turner, Noonan and Russell-Silver syndromes)
- Chronic diseases including malnutrition, coeliac disease, chronic inflammation, muscular dystrophy, thalassaemia, blood disorders, severe liver or kidney disease and severe cyanotic heart disease
- Chronic diseases requiring treatment with chronically administered corticosteroids
- Skeletal dysplasia
- Psychosocial short stature
- Patients having received irradiation, including total body irradiation
- Patients currently on GH or IGF-1 therapy or having received GH or IGF-1 therapy in the last 12 months
- Patients likely to require GH, IGF-1 or chronic corticosteroid treatment during the study
- Any mental condition that prevents both parents or Legally Acceptable Representatives and the child when applicable from understanding the nature, scope and possible consequences of the study, or any evidence of an uncooperative attitude
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients with a mean of the two basal IGF-1 measurements ≤-2.0 SDS, > -2.0 SDS and below 0 SDS, ≥ 0.0 SDS
Time Frame: Day 1 for the first sample; between Day 14 and Day 45 for the second sample
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Day 1 for the first sample; between Day 14 and Day 45 for the second sample
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients with height ≤ -3.0 SDS,and height > -3.0 SDS and ≤ -2.5 SDS
Time Frame: Day 1
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Day 1
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Description of mean basal IGF-1 and IGFBP-3 levels, and basal ALS and prolactin levels in patients with height ≤ -3.0 SDS, and height > -3.0 SDS and ≤ -2.5 SDS
Time Frame: Day 1 and Day 14-45
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Day 1 and Day 14-45
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Proportion of patients having presented at least one historical documented clinically significant episode of hypoglycaemia
Time Frame: Before the start of the study and during the study.
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Before the start of the study and during the study.
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Identification of candidate genes and/or DNA aberrations or changes potentially associated with short stature. DNA regions identified during the genome-wide scan will be further mapped at higher resolution (DNA-sequencing)
Time Frame: Day 1
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Day 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start
October 1, 2008
Primary Completion (ACTUAL)
January 1, 2010
Study Completion (ACTUAL)
January 1, 2010
Study Registration Dates
First Submitted
July 2, 2008
First Submitted That Met QC Criteria
July 3, 2008
First Posted (ESTIMATE)
July 4, 2008
Study Record Updates
Last Update Posted (ACTUAL)
January 15, 2019
Last Update Submitted That Met QC Criteria
January 11, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2-79-52800-001
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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