HealthyTHYRBECKNCT03748407
Determination of Baseline Thyroid Status Values in French Adult Population
A study testing Dosages of Thyroid parameters in people with Healthy, run by University Hospital, Caen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dosages of Thyroid parameters
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2018to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Donors (18-70 years old) volunteers at EFS
Who cannot join
- 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
About this study
Official title: Determination of Baseline Thyroid Status Values
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.
Read more
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
- Being tested
- Dosages of Thyroid parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dosages of Thyroid parametersOther
Dosages of the following parameters: TSH, FT4 FT3, TGAb (Tyroglobulin antibody) , TPO Ab (ThyroPeroxydase Antibody)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Dosages of Thyroid parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start30 Nov 2018 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completion31 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748407
- Sponsor's protocol ID
- 18-040
- Acronym
- THYRBECK
- Status last verified
- Nov 2018
- First submitted
- 30 Oct 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Baseline Thyroid Status Values
- ClinicalTrials.gov ID
- NCT03748407
- Acronym / sponsor ID
- THYRBECK / 18-040
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 30 Nov 2018 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 31 Jan 2019 (estimated)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dosages in Healthy volunteers | Other | Other: Dosages of Thyroid parametersOnly 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Donors (18-70 years old) volunteers at EFS
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dosages of Thyroid parametersDosages of the following parameters: TSH, FT4 FT3, TGAb (Tyroglobulin antibody) , TPO Ab (ThyroPeroxydase Antibody) | Other | dosages in Healthy volunteers |
Primary outcome
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dosages of Thyroid parameters in people with Healthy, run by University Hospital, Caen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the usual values of TSH (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.