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Determination of Baseline Thyroid Status Values in French Adult Population

Determination of Baseline Thyroid Status Values

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03748407
Acronym
THYRBECK
Enrollment
600
Registered
2018-11-20
Start date
2018-11-30
Completion date
2019-01-31
Last updated
2018-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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.

Interventions

OTHERDosages of Thyroid parameters

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

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Determination of the usual values of TSHbaselineDetermination 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 FT4baselineDetermination 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 FT3baselineDetermination 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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026