Determination of Baseline Thyroid Status Values in French Adult Population (THYRBECK)

Determination of Baseline Thyroid Status Values

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Other: Dosages of Thyroid parameters

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Anticipated): November 30, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): January 31, 2019

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): November 20, 2018
• Last Update Submitted That Met QC Criteria: November 19, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 18-040

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No