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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

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.


Condition or disease Intervention/treatment Phase
Healthy Other: Dosages of Thyroid parameters Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03748407     History of Changes
Other Study ID Numbers: 18-040
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No