NCT00710307已完成不适用
Descriptive, Cross-sectional and Prospective Epidemiology Study, on the Identification of Insulin-like Growth Factor-1 Status in Idiopathic Short Stature Children (EPIGROW Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- Proportion of patients with a mean of the two basal IGF-1 measurements ≤-2.0 SDS, > -2.0 SDS and below 0 SDS, ≥ 0.0 SDS
研究概览
简要总结
The purpose of the protocol is to describe the distribution of IGF-1 deficiency in the studied population of Idiopathic Short Children without Growth Hormone Deficiency or any other identified cause of short stature and not treated with recombinant Growth Hormone or IGF-1
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Short children, height ≤ -2.5 SDS
- •Age ≥ 2 years
- •With at least one normal or elevated peak GH response to a stimulatory test (peak GH ≥ 7 ng/mL) at the time of the study and/or at a given time-point during the last 12 months
- •Pre-pubertal
- •Signed Informed Consent, including agreement to have blood samples taken for hormonal measurement and genetic analysis, by both parents or by Legally Acceptable Representatives when applicable and the child when applicable
排除标准
- •The following identified causes of short stature:
- •GH-deficient short stature
- •Other endocrine causes (hypothyroidism, Cushing's syndrome, parathyroid or vitamin D disorders, hypogonadism)
- •Identified syndromes with genetic abnormalities (including Turner, Noonan and Russell-Silver syndromes)
- •Chronic diseases including malnutrition, coeliac disease, chronic inflammation, muscular dystrophy, thalassaemia, blood disorders, severe liver or kidney disease and severe cyanotic heart disease
- •Chronic diseases requiring treatment with chronically administered corticosteroids
- •Skeletal dysplasia
- •Psychosocial short stature
- •Patients having received irradiation, including total body irradiation
- •Patients currently on GH or IGF-1 therapy or having received GH or IGF-1 therapy in the last 12 months
- •Patients likely to require GH, IGF-1 or chronic corticosteroid treatment during the study
- •Any mental condition that prevents both parents or Legally Acceptable Representatives and the child when applicable from understanding the nature, scope and possible consequences of the study, or any evidence of an uncooperative attitude
结局指标
主要结局
Proportion of patients with a mean of the two basal IGF-1 measurements ≤-2.0 SDS, > -2.0 SDS and below 0 SDS, ≥ 0.0 SDS
时间窗: Day 1 for the first sample; between Day 14 and Day 45 for the second sample
次要结局
- Proportion of patients with height ≤ -3.0 SDS,and height > -3.0 SDS and ≤ -2.5 SDS(Day 1)
- Description of mean basal IGF-1 and IGFBP-3 levels, and basal ALS and prolactin levels in patients with height ≤ -3.0 SDS, and height > -3.0 SDS and ≤ -2.5 SDS(Day 1 and Day 14-45)
- Proportion of patients having presented at least one historical documented clinically significant episode of hypoglycaemia(Before the start of the study and during the study.)
- Identification of candidate genes and/or DNA aberrations or changes potentially associated with short stature. DNA regions identified during the genome-wide scan will be further mapped at higher resolution (DNA-sequencing)(Day 1)
研究者
研究点 (1)
Loading locations...
相似试验
终止
不适用
IGF-1, IGFBP3, ALS Normative Ranges in Healthy Pediatric Spanish PopulationIGF-1 DeficiencyNCT01676090Ipsen304
撤回
不适用
The Role of Igf-1 Generation Test in Diagnosis and Treatment of Short StatureShort StatureNCT01970800Maimonides Medical Center
暂停
2 期
Treatment of the lOw IGF-1 Syndrome aSsociated With Chronic Heart fAilure: A Randomized, Placebo-Controlled, Double-Blind Study.Chronic Heart FailureNCT01235273Federico II University100
Enrolling By Invitation
不适用
Functional GI Disease RegistryFunctional Gastrointestinal DisordersNCT05295446Massachusetts General Hospital500
已完成
不适用
Study to Evaluate Interferon Gamma (IFNγ) and Other Inflammatory Mediators in Patients With Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH)Hemophagocytic LymphohistiocytosisNCT03259230Light Chain Bioscience - Novimmune SA32