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Determination of Baseline Thyroid Status Values in French Adult Population

NCT03748407 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2018-11-20

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

OTHER

Dosages of Thyroid parameters

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

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-30
Primary Completion
2018-12-01
Completion
2019-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03748407 on ClinicalTrials.gov