Research

Eli Lilly Growth Study Program

The Genetics and NeuroEndocrinology of Short Stature International Study (GeNeSIS) Consent For Data Collection: Core Program

Protocol Description

The main objective of this multicenter international study is the collection and analysis of data regarding safety and effectiveness of Humatrope® for the treatment of growth-hormone deficiency and other growth disorders. This study provides information to doctors prescribing growth hormone to treat children and adolescents, ultimately helping physicians to use these products more effectively.

The GeNeSIS study includes a core study and 5 sub-study modules: DNA Analysis, Growth Prediction, SHOX Deficiency, Neoplasia, and Idiopathic Short Stature. Objectives of the sub-studies are: to characterize gene defects associated with hypopituitarism, growth disorder or short stature; to develop accurate growth prediction models using clinical and biochemical data; to characterize the clinical, endocrine and other features associated with SHOX deficiency and related disorders; to characterize the natural history of neoplastic disease in children evaluated or treated for endocrine or growth disorders; and to examine the variability among genes, proteins and other biomarkers that may be related to growth in children in the United States who receive Humatrope for treatment of idiopathic short stature.

Eligibility Criteria

Children of either sex who are being treated with Humatrope for growth failure are eligible to participate in the core study. Core study participants may also participate in applicable sub studies, through separate consents.
Boys: All ages
Girls: All ages

Requirements
Participation will only involve data collection and annual blood draws, starting during each participant’s first treatment with growth hormone and will continue during subsequent routine visits with the child’s doctor. The study will collect and record all medical record information from lab tests, x-rays and clinic visits.
Visits: None beyond normal clinical care
Duration: Until patient is no longer seen in clinic

Status: Open for Enrollment

Source of Support
Eli Lilly and Company

Primary Investigator(s)

Oscar Escobar, MD

Contact Information

To get started, please contact:
Ana Diaz, RN
412-692-6862 or
Virginia Stefanick, RN
412-692-7178

Last Update
March 5, 2014
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Last Update
March 5, 2014
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