Validation of a New TSH Test

Study Overview
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Brief Summary
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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.

Official Title
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Validation of a New TSH Test for Early Screening of Hypothyroidism

Conditions
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Sub-clinical Hypothyroidism, Hypothyroidism, Euthyroidism

Intervention / Treatment
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* Other: Blood sample


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: less than 60 years old with clinical symptom of hypothyroidism<br>Group of patients less than 60 years old, with at least one clinical symptom of hypothyroidism | Other: Blood sample<br>* An extra blood sample of 10 ml is collected<br>|
| Experimental: less than 60 years old without clinical symptoms<br>Group of patients less than 60 years old, without clinical symptoms of hypothyroidism | Other: Blood sample<br>* An extra blood sample of 10 ml is collected<br>|
| Experimental: more than 60 years old<br>Group of patients more than 60 years old at recruitment. | Other: Blood sample<br>* An extra blood sample of 10 ml is collected<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Measurement of sensibility and specificity and determination of the cut-off value of the new TSH test proposed by Siamed'Xpress Study of the association between TSH measurements obtained with the different techniques (IRMA vs new technique proposed by Siamed'Xpress) Study of the concordance of the different diagnostic tests for hypothyroidism detection | Recruitment period : 30 months (starting from February 2012) in order to establish a serum bank | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TSH Testing, sub-clinical hypothyroidism