Disease-oriented Russian Disc Degeneration Study (RuDDS) Biobank Facilitating Functional Omics Studies of Lumbar Disc Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,070
- 试验地点
- 3
- 主要终点
- Genotyping
研究概览
简要总结
The main aim of this study is to establish disease-oriented biobank to facilitate research in biology of the lumbar disc degeneration. Diverse biological samples (whole blood, plasma, disc tissue) along with MRI imaging, clinical, socio-demographic and various omics data (e.g. genomic and transcriptomic) will be available for researchers and clinicians for a variety of further multi-omics studies. It will lay the groundwork for the development of early diagnostics of DDD and its personalized treatment.
The study is planned to enroll up to 1,100 patients with different grades of lumbar disc degeneration. It is planned to recruit patients within 36 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18;
- •Presence of lumbar MRI scans;
- •Signed informed consent for voluntary participation is provided.
排除标准
- •Any contraindication or inability to undergo baseline procedures;
- •Prior surgeries at any level of the lumbar spine;
- •Other non-degenerative spinal conditions that may have an impact on subject safety, wellbeing or the intent and conduction of the study;
- •History or presence of HIV, hepatitis B, hepatitis C.
结局指标
主要结局
Genotyping
时间窗: Through 3 years
DNA will be extracted from the whole blood samples according to the standard protocol
次要结局
- Total RNA profiling(Through 3 years)
- Total plasma proteins N-glycosylation profiling(Through 3 years)
- Phenotype of patients with lumbar disc degeneration(Through 3 years)