Genisis: The Genetics and Neuroendocrinology of Short Stature International Study (A Post-Marketing Research Program)
The Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS) is a multinational, multicenter, post-marketing research program that is evaluating the long-term safety and effectiveness of Humatrope® (somatropin [rDNA origin] for injection) therapy in pediatric patients. In addition to tracking the long-term safety and effectiveness of Humatrope in the observational setting GeNeSIS includes four sub-studies:
Genetic Analysis Sub-study - investigating the genetic alterations underlying various growth disorders
Growth Prediction Sub-study - refining models to accurately predict growth response to GH treatment
SHOX Deficiency Sub-study - elucidating the clinical, endocrine, genetic and radiological features of patients with SHOX deficiency (including patients with Turner syndrome)
Neoplasia Sub-study - monitoring progression or recurrence of neoplastic disease in children with a history of neoplasia.