Observational Study of Somatropin Treatment in Children
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dwarfism, Growth Hormone Deficiency; Turner Syndrome; Infant, Small for Gestational Age; SHOX Protein, Human
Intervention: Somatropin (rDNA origin) (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): 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), Study Director, Affiliation: Eli Lilly and Company
Summary
GeNeSIS is an open-label, multinational, multicenter, observational study to evaluate the
safety and effectiveness of Humatrope treatment.
GeNeSIS is a modular program that includes:
- Core study: Evaluating the safety and effectiveness of Humatrope in the observational
setting
- Genetic Analysis Sub-study: Investigating the genetic defects underlying growth hormone
(GH) deficiency and non-GH-deficient growth disorders
- Growth Prediction Sub-study: Working to validate and refine specific models to
accurately predict growth response to GH
- SHOX Deficiency Sub-study: Elucidating the clinical, endocrine and radiological
features of patients with SHOX deficiency due to loss of, or mutation in the SHOX gene
(including patients with Turner syndrome)
- Neoplasia Sub-study: To characterize the natural history of neoplastic disease,
especially in relation to recurrence/progression of primary neoplasia or development of
secondary neoplasia in children with a history of neoplasia
Clinical Details
Official title: The Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS)
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Standardized Incidence Ratio for Type 2 Diabetes Mellitus in Somatropin-Treated ChildrenStandardized Incidence Ratio for De Novo Cancer in Somatropin-Treated Children Baseline Height, Final Height, Height Gain in Somatropin-Treated Children
Secondary outcome: Percentage of Participants with Defects in Genes Associated with Pituitary DevelopmentPredicted First Year Height Gain Versus Actual First Year Height Gain Change from Baseline to Final Height in Anthropometric Measures for Participants with SHOX Deficiency Percentage of Participants with Recurrent Tumors and Second Neoplasms Percentage of Participants with De Novo Neoplasms Standardized Incidence Ratio for Diabetes Mellitus in Somatropin-Treated Children with Different Short Stature Diagnoses
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: April 1999
Last updated: August 10, 2015
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