Status unknownNCT03748407THYRBECKUpdated Nov 20, 2018

Determination of Baseline Thyroid Status Values in French Adult Population

An interventional study of Dosages of Thyroid parameters in Healthy, sponsored by University Hospital, Caen. Status unknown. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-20.

Sponsored by University Hospital, Caen · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Nov 2018), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 600
Allocation: Not applicable
Ages: 18 Years to 70 Years
Sex: All

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 studied

Healthy

In context

Lead sponsor

University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Donors (18-70 years old) volunteers at EFS

Exclusion criteria

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

Study design

Phase: Not applicable
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 600 participants (estimated)

Study arms

Other
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

Interventions

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

What researchers measure

Primary outcomes

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)
Time frame: 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)
Time frame: 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)
Time frame: baseline

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03748407
Lead sponsor: University Hospital, Caen
Responsible party: Sponsor
First posted: Nov 20, 2018
Start date: Nov 30, 2018 (estimated)
Primary completion: Dec 1, 2018 (estimated)
Completion: Jan 31, 2019 (estimated)
Last update: Nov 20, 2018

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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