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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


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


- 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 Children

Standardized 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 Development

Predicted 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


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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