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 * Short Stature Homeobox containing gene (SHOX) Deficiency Sub-study: Elucidating the clinical, endocrine and radiological features of participants with SHOX deficiency due to loss of, or mutation in the SHOX gene (including participants 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
Study Type
OBSERVATIONAL
Enrollment
22,845
Dose, frequency and duration at discretion of attending physician.
Type 2 Diabetes Mellitus in GH-treated Participants
Time frame: Year 15
Primary Malignancies in Participant Without Previous Cancer History
Due to the small number of participants involved, untreated and unknown treatment groups, data was not provided and could not be calculated.
Time frame: Year 15
Final Height (FH) Gain by Diagnostic Group
The standard deviation score (SDS) reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height. Due to the small number of participants involved, untreated and unknown treatment groups, data was not provided and could not be calculated.
Time frame: Baseline through Year 15
Percentage of Participants With Defects in Genes Associated With Pituitary Development
Percentage of participants with genetic defects associated with pituitary development. Genes included but were not limited to GH1, Growth hormone releasing hormone receptor (GHRHR), Homeobox gene expressed in embryonic stem cells (HESX1), LIM homeobox 3 (LHX3), POU domain, class 1, transcription factor 1 (POU1F1), and Prophet of Pit1 (PROP1).
Time frame: Baseline through Year 15
Predicted First Year Height Gain Versus Actual First Year Height Gain
The value for predicted and observed is of limited bearing, it is how each participant's predicted versus observed height gain compare and this is best estimated by the R-squared. An estimation parameter would not be a correct format for the R2 data. R2 can take value between 0 and 1 with values closer to 0 representing a poor fit while values closer to 1 representing a perfect fit
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 Neoplasms and Second Neoplasms in Childhood Cancer Survivors
Percentage of participants with recurrence/progression of primary neoplastic disease and/or development of secondary neoplasms in childhood cancer survivors.
Time frame: Baseline through Year 15
Percentage of Participants With De Novo Neoplasms
Percentage of participants with the development of de novo neoplastic disease with no history of prior neoplasia.
Time frame: Baseline through Year 15
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
Time frame: Baseline through Year 15
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