Determination of Baseline Thyroid Status Values in French Adult Population (THYRBECK)
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|ClinicalTrials.gov Identifier: NCT03748407|
Recruitment Status : Not yet recruiting
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Other: Dosages of Thyroid parameters||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Determination of Baseline Thyroid Status Values|
|Estimated Study Start Date :||November 30, 2018|
|Estimated Primary Completion Date :||December 1, 2018|
|Estimated Study Completion Date :||January 31, 2019|
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.
Other: Dosages of Thyroid parameters
Dosages of the following parameters: TSH, FT4 FT3, TGAb (Tyroglobulin antibody) , TPO Ab (ThyroPeroxydase Antibody)
- Determination of the usual values of TSH [ Time Frame: 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)
- Determination of the usual values of FT4 [ Time Frame: 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 FT3 [ Time Frame: 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)