Observational Study of Somatropin Treatment in Children (GeNeSIS)
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ClinicalTrials.gov Identifier: NCT01088412 |
Recruitment Status
:
Completed
First Posted
: March 17, 2010
Last Update Posted
: October 26, 2015
|
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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
Condition or disease | Intervention/treatment |
---|---|
Dwarfism, Growth Hormone Deficiency Turner Syndrome Infant, Small for Gestational Age SHOX Protein, Human | Drug: Somatropin (rDNA origin) |
Study Type : | Observational |
Actual Enrollment : | 22929 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS) |
Study Start Date : | April 1999 |
Actual Primary Completion Date : | September 2015 |
Actual Study Completion Date : | September 2015 |

Group/Cohort | Intervention/treatment |
---|---|
Treated
Patients treated with somatropin for improvement of growth
|
Drug: Somatropin (rDNA origin)
Dose, frequency and duration at discretion of attending physician.
Other Names:
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Untreated
Untreated patients with presence or history of neoplastic disease evaluated for endocrine or growth disorder or with any SHOX deficiency related disorder
|
- Standardized Incidence Ratio for Type 2 Diabetes Mellitus in Somatropin-Treated Children [ Time Frame: Year 15 ]
- Standardized Incidence Ratio for De Novo Cancer in Somatropin-Treated Children [ Time Frame: Year 15 ]
- Baseline Height, Final Height, Height Gain in Somatropin-Treated Children [ Time Frame: Baseline through Year 15 ]
- Percentage of Participants with Defects in Genes Associated with Pituitary Development [ Time Frame: Baseline through Year 15 ]
- Predicted First Year Height Gain Versus Actual First Year Height Gain [ Time Frame: Baseline through Year 15 ]
- Change from Baseline to Final Height in Anthropometric Measures for Participants with SHOX Deficiency [ Time Frame: Baseline, Year 15 ]
- Percentage of Participants with Recurrent Tumors and Second Neoplasms [ Time Frame: Baseline through Year 15 ]
- Percentage of Participants with De Novo Neoplasms [ Time Frame: Baseline through Year 15 ]
- Standardized Incidence Ratio for Diabetes Mellitus in Somatropin-Treated Children with Different Short Stature Diagnoses [ Time Frame: Baseline through Year 15 ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01088412
Study Director: | 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) | Eli Lilly and Company |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT01088412 History of Changes |
Other Study ID Numbers: |
2712 B9R-EW-GDFC ( Other Identifier: ELI Lilly and Company ) |
First Posted: | March 17, 2010 Key Record Dates |
Last Update Posted: | October 26, 2015 |
Last Verified: | October 2015 |
Additional relevant MeSH terms:
Dwarfism, Pituitary Dwarfism Turner Syndrome Gonadal Dysgenesis Primary Ovarian Insufficiency Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine Hypopituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Endocrine System Diseases Disorders of Sex Development Urogenital Abnormalities Sex Chromosome Disorders of Sex Development Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities Sex Chromosome Disorders Chromosome Disorders Genetic Diseases, Inborn Gonadal Disorders Ovarian Diseases Adnexal Diseases |