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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Chambéry、フランス、73000
- Centre Hospitalier de Chambery
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Pierre-Bénite、フランス、69495
- Centre Hospitalier LYON SUD
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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実験的：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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)
時間枠：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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協力者と研究者
スポンサー
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2011.672
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。