The Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS) - GeNeSIS
- Conditions
- Short Stature
- Registration Number
- EUCTR2006-001721-26-LT
- Lead Sponsor
- AB Eli Lilly Lietuva”
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 13000
Core programme: all patients treated with Humatrope for growth promotion
DNA analysis sub-study: patients who fulfil the scoring criteria
Growth prediction sub-study: therapy-naïve patients
SHOX deficiency sub-study: patients with Turner syndrome, Léri-Weill or Langer syndrome (with or without SHOX defect), or other growth disorder with proven SHOX defect, treated or non-treated (control group)
Neoplasia sub-study: patients with a history of neoplasia and endocrine or growth disorder, treated or non-treated (control group)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Patients treated long-term data on efficacy of GH treatment
with other HGH
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Collect long-term safety and efficacy data on Humatrope in pediatrics;Secondary Objective: Develop new science (e.g. genetics of GHD, SHOX deficiency)<br>Provide services to physicians and fill gaps (e.g. DNA analyses, growth prediction for dose adjustments, IGF measurements;Primary end point(s): To collect clinical, biochemical and genetic data<br>To identify non-responders early<br>To optimize dose for individual needs<br>To monitor compliance<br>To verify the diagnosis<br>To identify additional problems (e.g. unregognized hypothyroidism)<br>Long-term data on safety and efficacy of GH treatment<br>
- Secondary Outcome Measures
Name Time Method