Determination of Baseline Thyroid Status Values in French Adult Population

NCT03748407 | Unknown

• 1 other identifier: 18-040
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

dosages in Healthy volunteers

OTHER

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

Interventions

Dosages of Thyroid parameters OTHER

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

dosages in Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Donors (18-70 years old) volunteers at EFS

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 20, 2018
• Study Start: November 30, 2018
• Primary Completion: December 1, 2018
• Study Completion: January 31, 2019
• Last Updated: November 20, 2018

Record last verified: 2018-11