Determination of Baseline Thyroid Status Values in French Adult Population

Healthy Clinical Trial

— THYRBECK  

Official title:

Determination of Baseline Thyroid Status Values

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03748407
• Other study ID #: 18-040
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 30, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: November 2018
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: January 31, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Dosages of Thyroid parameters
Dosages of the following parameters: TSH, FT4 FT3, TGAb (Tyroglobulin antibody) , TPO Ab (ThyroPeroxydase Antibody)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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