Determination of Baseline Thyroid Status Values
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 主要终点
- Determination of the usual values of FT3
研究概览
简要总结
The objective of this study is to establish reference values in the general population from a Beckman Coulter DxI chemiluminescence assay.
Indeed, the lack of harmonization of the methods of the dosage remains a major difficulty to optimize the management of patients with thyroid disease.
This supplier has recently optimized its dosing kit according to the 3rd international standard of the WHO (IRB 81/565) for the TSH (Thyroid Stimulating Hormon).
It is necessary to carry out a study of the distribution of the values of this TSH within our metropolitan population. The current data proposed by the supplier come from a study of a North American population.
investigators propose to define usual values for thyroid status markers (TSH, FT4 [free thyroxine], FT3 [free triiodothyroxine]) from healthy EFS (French Blood Establishment) donors who meet the standard exclusion criteria for this type of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Donors (18-70 years old) volunteers at EFS
排除标准
- •pregnancy,
- •known antecedents of thyroid diseases (goiter, nodule, hypo or hyperthyroidism),
- •current antithyroid treatment (neomercazole [Thyrozol(r)], levothyroxyn LT4 [levothyrox(r)], ...),
- •cardiac treatment with amiodarone (cordarone(r)),
- •injection of iodinated contrast medium less than 1 month old
研究组 & 干预措施
dosages in Healthy volunteers
Only one arm : healthy volunteer blood donors. Performing a blood test for the determination of parameters that explore thyroid status : only once.
Absence of other healthy volunteers group all healthy volunteers have a blood test performed in the same way.
干预措施: Dosages of Thyroid parameters (Other)
结局指标
主要结局
Determination of the usual values of FT3
时间窗: baseline
Determination of the usual values of FT3 after assays on DxI automaton of the Beckman Company according to the standardization 3rd international standard (IRB 81/565)
Determination of the usual values of FT4
时间窗: baseline
Determination of the usual values of FT4 after assays on DxI automaton of the Beckman Company according to the standardization 3rd international standard (IRB 81/565)
Determination of the usual values of TSH
时间窗: baseline
Determination of the usual values of TSH after assays on DxI automaton of the Beckman Company according to the standardization 3rd international standard (IRB 81/565)
次要结局
未报告次要终点