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Observational Study of Somatropin Treatment in Children (GeNeSIS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01088412
First received: February 25, 2010
Last updated: October 23, 2015
Last verified: October 2015
  Purpose

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 Intervention
Dwarfism, Growth Hormone Deficiency Turner Syndrome Infant, Small for Gestational Age SHOX Protein, Human Drug: Somatropin (rDNA origin)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
If patient consented a DNA sample is kept until the end of the study

Enrollment: 22929
Study Start Date: April 1999
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Treated
Patients treated with somatropin for improvement of growth
Drug: Somatropin (rDNA origin)
Dose, frequency and duration at discretion of attending physician.
Other Names:
  • Humatrope
  • LY137998
Untreated
Untreated patients with presence or history of neoplastic disease evaluated for endocrine or growth disorder or with any SHOX deficiency related disorder

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Clinics and private practices
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088412

Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

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 )
Study First Received: February 25, 2010
Last Updated: October 23, 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

ClinicalTrials.gov processed this record on August 23, 2017