Genisis: The Genetics and Neuroendocrinology of Short Stature International Study (A Post-Marketing Research Program)

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Investigator: Stephen M. Rosenthal, MD
Sponsor: Lilly Research Laboratories

Description

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.