Viral Infection of Lymphoid Cells Occuring at the First Manifestation of Idiopathic Nephrotic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 401
- 试验地点
- 1
- 主要终点
- Hybridization of viral genome will be studied at the first manifestation of idiopathic nephrotic syndrome
研究概览
简要总结
The primary purpose of the study is to evaluate the association of a latent infection of lymphoid cells during the first manifestation of steroid sensitive nephrite syndrome. The thirty nine units of general pediatrics and pediatric nephrite covering the parisian area will participate to the study. We speculate that hybridization of the genome, or a part of the genome, of a virus in lymphoid cells is responsible specific changes of genes expression, leading to the development of the disease.
详细描述
An additional blood volume will be sampled in patients and controls during a scheduled biological check-up for the initial disease and viral genome of EBV, CMV, HHV6, HHV7 as well as adenovirus will be searched for using PCR reaction in total blood DNA extract. The frequency of a latent hybridization of virus genome within human genome will be compared between patients with steroid sensitive nephrotic syndrome and controls matched for age and sex. Secondary studies will include a comparison of steroid dependency in nephrotic patients according to the occurence of a latent viral hybridization, the epidemiology of idiopathic nephrotic syndrome in the Parisian area and a pharmacogenetic analysis of steroid sensitivity and dependency. If necessary, the chromosomal localization of viral hybridization will be studied with fluorescence in situ hybridization using specific probes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •proteinuria over 0.25 g/mmol of creatinine with hypoalbuminemia below 30g/L for the case
- •No history of renal disease
- •Normal C3 and negativity for hepatitis B and C
排除标准
- •no medical insurance
- •inclusion in another study
结局指标
主要结局
Hybridization of viral genome will be studied at the first manifestation of idiopathic nephrotic syndrome
时间窗: Within the 3 days of the first manifestation
次要结局
- Steroid sensitivity will be checked by 1 month of prednisone therapy according to the recommendation of the " SOCIETE DE NEPROLOGIE PEDIATRIQUE" and steroid dependency will be checked at 4.5 months of prednisone therapy.(4.5 months)