Validation of a New TSH Test
Validation of a New TSH Test for Early Screening of Hypothyroidism
The aim of this research project, which is realised with the partnership of the enterprise Siamed'Xpress (Marseille), is to validate a new TSH diagnostic test in vitro, to allow an earlier screening of hypothyroidism. A serum bank will be conserved in the "Centre de Biologie Sud" ("Groupement Hospitalier Lyon Sud").
The serum samples will be assayed locally for the usual medical support to patients and after they will be sent to Siamed'Xpress (Marseille), where they will be assayed with the new diagnostic test. The results obtained from the two techniques will be compared.
The validation of this new TSH test represents a major advancement, since it could bring in the future to a therapeutic index which will allow clinicians to treat earlier asymptomatic patients with subclinical hypothyroidism.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Chambéry、法国、73000
- Centre Hospitalier de Chambery
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Pierre-Bénite、法国、69495
- Centre Hospitalier LYON SUD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Subjects more than 18 years old
- Thyroid test planned in the normal health care of patients
- Subject who has been informed about "TSH Testing" study with a complete Subject Information Sheet and who has signed a consent form
- Subject covered by the Health Social System
Exclusion Criteria:
- Subjects with hyperthyroidism (clinical symptoms : weight loss with unaltered appetite, palpitations in the absence of cardio-vascular pathology, unusual and recent nervousness)
- Subject not covered by the Health Social System
- Subject who already participates to another clinical research study, which might interfere with TSH Testing Study
- Pregnant, parturient or breastfeeding mother
- Person deprived of freedom by a judicial or administrative decision
- Person under a legal guardianship or unable to consent (MMSE score < 20/30 for the patients for whom this test has been performed).
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：less than 60 years old with clinical symptom of hypothyroidism
Group of patients less than 60 years old, with at least one clinical symptom of hypothyroidism
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An extra blood sample of 10 ml is collected
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实验性的：less than 60 years old without clinical symptoms
Group of patients less than 60 years old, without clinical symptoms of hypothyroidism
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An extra blood sample of 10 ml is collected
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实验性的：more than 60 years old
Group of patients more than 60 years old at recruitment.
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An extra blood sample of 10 ml is collected
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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TSH assay of all the patients samples conserved in the serum bank with two techniques: technique IRMA (Immuno Radiometric Assay) and the new technique developed by Siamed'Xpress (Marseille)
大体时间：Recruitment period : 30 months (starting from February 2012) in order to establish a serum bank
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Recruitment period : 30 months (starting from February 2012) in order to establish a serum bank
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合作者和调查者
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
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