The Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS)
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Open (Enrolling by invite only)
Both
Dwarfism, Growth Hormone Deficiency, Turner Syndrome, Infant, Small for Gestational Age, SHOX Protein, Human
Both
Dwarfism, Growth Hormone Deficiency, Turner Syndrome, Infant, Small for Gestational Age, SHOX Protein, Human
Trial Information
The Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS)
Inclusion Criteria:
All patients participating in GeNeSIS must be enrolled in the core study. Patients for
whom written consent to release information is provided may enter the core study if they
meet any of the following inclusion guidelines:
- Treatment with Humatrope for improvement of growth.
- No treatment with somatropin in patients with a history of neoplasia or in those with
any SHOX-related disorder.
Exclusion Criteria:
- Patients with closed epiphyses are not eligible for GeNeSIS entry. However, patients
may remain in the study if epiphyseal closure occurs during study participation.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Incidence of type 2 diabetes mellitus in somatropin-treated children
Outcome Time Frame:
Will be analyzed at study completion
Safety Issue:
Yes
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
Australia: Human Research Ethics Committee
Study ID:
2712
NCT ID:
NCT01088412
Start Date:
April 1999
Completion Date:
September 2015
Related Keywords:
- Dwarfism, Growth Hormone Deficiency
- Turner Syndrome
- Infant, Small for Gestational Age
- SHOX Protein, Human
- Dwarfism
- Dwarfism, Pituitary
- Turner Syndrome
- Gonadal Dysgenesis
- Primary Ovarian Insufficiency
- Endocrine System Diseases
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