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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Procedure | Blood samples will be collected at visit 1 (day 1) and at visit 2 (day 14 to 45). | ||
| Genetic analysis | Genetic | The sample for genetic analyses may be taken at Visit 1. The blood sample volume will be 6 mL. |
| Measure | Description | 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 | Day 1 for the first sample; between Day 14 and Day 45 for the second sample |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with height ≤ -3.0 SDS,and height > -3.0 SDS and ≤ -2.5 SDS | Day 1 | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Idiopathic Short Stature children
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ipsen Central Contact | Paris | France |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D005820 | Genetic Testing |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Whole blood will be collected. The blood sample will be kept as long as necessary and for a maximum of 5 years.
| Day 1 and Day 14-45 |
| Proportion of patients having presented at least one historical documented clinically significant episode of hypoglycaemia | Before the start of the study and during the study. |
| 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) | Day 1 |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |