Determination of Baseline Thyroid Status Values in French Adult Population

Study Overview
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Brief Summary
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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.

Official Title
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Determination of Baseline Thyroid Status Values

Conditions
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Healthy

Intervention / Treatment
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* Other: Dosages of Thyroid parameters


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Donors (18-70 years old) volunteers at EFS Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: dosages in Healthy volunteers<br>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. | Other: Dosages of Thyroid parameters<br>* Dosages of the following parameters: TSH, FT4 FT3, TGAb (Tyroglobulin antibody) , TPO Ab (ThyroPeroxydase Antibody)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the usual values of TSH | 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) | baseline | 
| Determination of the usual values of FT4 | 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) | baseline | 
| Determination of the usual values of FT3 | 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) | baseline |