Evaluation of Biological Variability in Cartilage Specific Biomarkers (Coll2-1, Coll2-1NO2, FIB3-1 and FIB 3-2) in Healthy Volunteers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Artialis
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Variation of serum and urine sample between baseline, weeks 2, 16, 52 and 68 to assess intra-individual biological variability of cartilage-specific biomarkers Coll2-1/Coll2-1NO2 / FIB3-1 and FIB3-2.
研究概览
简要总结
The purposes of the study are to assess intra individual biological variability of serum and urinary cartilage specific biomarkers and define the best standardized conditions for blood and urine sampling in the frame of biomarkers dosage.
详细描述
To assess intra individual biological variability of serum and urinary cartilage specific biomarkers and define the best standardized conditions for blood and urine sampling in the frame of biomarkers dosage. Variation factors assessed are:
- Fasting condition
- Sampling time
- Sampling season
- Physical activity
- Duration and temperature of total blood treatment
- Type of blood collection tube.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged above 18 years.
- •Sign an informed consent after being informed
- •Able to follow the instructions of the study
排除标准
- •Serious associated diseases:
- •Severe liver disease
- •Renal failure
- •hepatitis B or C
- •Patient who are the subject of a judicial protection measure or under guardianship
结局指标
主要结局
Variation of serum and urine sample between baseline, weeks 2, 16, 52 and 68 to assess intra-individual biological variability of cartilage-specific biomarkers Coll2-1/Coll2-1NO2 / FIB3-1 and FIB3-2.
时间窗: Baseline and weeks 2, 16, 52 and 68
Change from baseline will be assess by biomarkers dosage using ELISA (Enzyme Linked ImmunoAssay)
次要结局
未报告次要终点