Thyroid DisordersIFCC-TSHNCT05151120
Harmonization of Thyroid-stimulating Hormone Immunoassays Reagents
An observational study of Thyroid Disorders and Thyroid Stimulating; Hormone, C, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Given the prevalence and gravity of thyroid disorders, timely diagnosis, initiation, and monitoring of therapy are important to restrict the impact of the disease on public health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Disorders, Thyroid Stimulating; Hormone, C
- What is being tested?
- blood sample
- How many people
- 28 participants
- Where
- 2 sitesFrance
- Study dates
- 5 May 2022to 27 Nov 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The recruitment will be performed from the clinical cohort of thyroid disorder patients followed at the Hospices Civils de Lyon Hospital.
Who may be able to join
- Male or female ≥ 18 years of age
- Body weight ≥ 62 kg
- With a thyroid disorder (with high, low or normal TSH levels)
- Competent to give non opposition after information
Who cannot join
- Age <18 years old
- Those individuals previously enrolled into this clinical study
- Individuals diagnosed with a severe non-thyroidal illness at physician's appreciation. Defined as a state of dysregulation where levels of T3, T4, free triiodothyronine (FT3) and/or free thyroxine (FT4) are abnormal although the Thyroid gland does not appear to be dysfunctional. In practice, non-thyroidal illness (NTI) is reported to be usually associated with critical illness or starvation. Examples: chronic renal failure, liver cirrhosis, advanced (active) malignancy, sepsis, trauma, prolonged fasting or starvation, heart failure, Myocardial infarction (MI), and any psychiatric disorder.
- Pregnancy - please note that pregnancy test is not needed, a declaration is sufficient. The inclusion of a sample from a woman with an unidentified pregnancy will not jeopardize the study.
- Patient under guardianship and under legal protection
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service D'endocrinologie - Hôpital Louis Pradel - Hospices Civils de Lyon
Bron, 69 677
Service de Médecine Nucléaire - Hôpital Louis Pradel - Hospices Civils de Lyon
Bron, 69 677
About this study
Official title: Harmonization of Thyroid-stimulating Hormone Immunoassays Reagents - Blood Collection From Patients With Thyroid Disorders
Given the prevalence and gravity of thyroid disorders, timely diagnosis, initiation, and monitoring of therapy are important to restrict the impact of the disease on public health. Measurement of serum thyroid stimulating hormone (TSH) concentrations is an indispensable tool to confirm the disease and clinical management.
Reference intervals (RI) reported along with the laboratory data are an integral part of the interpretation process. Since many laboratory measurements are not yet comparable, RIs are typically established for each assay and are considered assay-specific. In this context, physicians who request test results from different laboratories are faced with challenges owing to different RIs. Assay-specific RIs are also problematic for patients who are seen by different doctors/different countries and more generally, assay-specific measurement results limit the development of modern public health standards.
Read more
Paramount to the goal of using common RIs is the establishment of metrological traceability of in vitro diagnostic (IVD) medical devices-also called standardization. As the International Federation of Clinical Chemistry (IFCC) Committee for Standardization of Thyroid Function Tests (C-STFT) members, the investigators decided to focus efforts on immunoassays for TSH in partnership with the IVD industry.
Although a reference measurement procedure existed for free thyroxine, the investigators considered this option for TSH unlikely and developed a pragmatic approach to harmonization rather than standardization.
Harmonization is important in order to guarantee comparability of results obtained in different laboratories. The harmonization process is conducted by assigning target values to a large set of samples, based on the results obtained by as many IVD-manufacturers as possible (ref 2). Important here is the fact that these samples must cover the full measuring range of a TSH assay, and so it is necessary to include samples from people with thyroid disease.
The primary objective of the study is the constitution of blood samples collection from patients with thyroid disorders in order to harmonize several commercially available immunoassays used for the determination of thyroid hormone concentrations in the blood.
- Conditions
- Thyroid Disorders, Thyroid Stimulating; Hormone, C
- Being tested
- blood sample
- Keywords
- Blood Sample collection, TSH results harmonisation, IVD-manufacturers, Reference intervals, Results harmonisation
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
In practice the only intervention of the study is 49 mL extra blood along with the blood draw that is already planned for diagnosis/follow-up
| Study group | Role | What they receive |
|---|---|---|
| Group A: Hyperthyroid | 30 patients will be included and divided into three categories: A1: 10 patients with suppressed TSH, around 0.01 milli-international unit/liter (mIU/L) A2: 10 patients with TSH values between 0.01 - 0.1 mIU/L A3: 10 patients with TSH values between 0.1 - 0.4 mIU/L Receives: Biological: blood sample | |
| Group B: Euthyroid | 30 Patients (under treatment) with TSH values between 0.4 - 4 mIU/L will be included Receives: Biological: blood sample | |
| GROUP C: Hypothyroid | 40 patients will be included and divided into two categories: C1: 20 patients with TSH values between 4 - 50 mIU/L C2: 20 patients with TSH values > 50 mIU/L up to 100 mIU/L. Even distribution (if possible). Receives: Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjet included
The primary objective is to collect 100 blood samples that distributed into the followings groups:
GROUP A: Hyperthyroid (N = 30) A1: 10 patients with suppressed TSH, around 0.01 mIU/L A2: 10 patients with TSH values between 0.01 - 0.1 mIU/L A3: 10 patients with TSH values between 0.1 - 0.4 mIU/L
GROUP B: Euthyroid (N = 30) Patients (under treatment) with TSH values between 0.4 - 4 mIU/L
GROUP C: Hypothyroid (N = 40) C1: 20 patients with TSH values between 4 - 50 mIU/L C2: 20 patients with TSH values > 50 mIU/L up to 100 mIU/L.
Measured: through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start5 May 2022
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DisordersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151120
- Sponsor's protocol ID
- 69HCL21_0806
- Other IDs
- 2021-A02187-34
- Acronym
- IFCC-TSH
- Status last verified
- Jan 2026
- First submitted
- 21 Oct 2021
- Last updated
- 26 Jan 2026
- 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harmonization of Thyroid-stimulating Hormone Immunoassays Reagents - Blood Collection From Patients With Thyroid Disorders
- ClinicalTrials.gov ID
- NCT05151120
- Acronym / sponsor ID
- IFCC-TSH / 69HCL21_0806
- Conditions
- Thyroid Disorders, Thyroid Stimulating; Hormone, C
- Keywords
- Blood Sample collection, TSH results harmonisation, IVD-manufacturers, Reference intervals, Results harmonisation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 9 Dec 2021 (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.
Given the prevalence and gravity of thyroid disorders, timely diagnosis, initiation, and monitoring of therapy are important to restrict the impact of the disease on public health. Measurement of serum thyroid stimulating hormone (TSH) concentrations is an indispensable tool to confirm the disease and clinical management.
Reference intervals (RI) reported along with the laboratory data are an integral part of the interpretation process. Since many laboratory measurements are not yet comparable, RIs are typically established for each assay and are considered assay-specific. In this context, physicians who request test results from different laboratories are faced with challenges owing to different RIs. Assay-specific RIs are also problematic for patients who are seen by different doctors/different countries and more generally, assay-specific measurement results limit the development of modern public health standards.
Paramount to the goal of using common RIs is the establishment of metrological traceability of in vitro diagnostic (IVD) medical devices-also called standardization. As the International Federation of Clinical Chemistry (IFCC) Committee for Standardization of Thyroid Function Tests (C-STFT) members, the investigators decided to focus efforts on immunoassays for TSH in partnership with the IVD industry.
Although a reference measurement procedure existed for free thyroxine, the investigators considered this option for TSH unlikely and developed a pragmatic approach to harmonization rather than standardization.
Harmonization is important in order to guarantee comparability of results obtained in different laboratories. The harmonization process is conducted by assigning target values to a large set of samples, based on the results obtained by as many IVD-manufacturers as possible (ref 2). Important here is the fact that these samples must cover the full measuring range of a TSH assay, and so it is necessary to include samples from people with thyroid disease.
The primary objective of the study is the constitution of blood samples collection from patients with thyroid disorders in order to harmonize several commercially available immunoassays used for the determination of thyroid hormone concentrations in the blood.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Hyperthyroid | – | Biological: blood sample30 patients will be included and divided into three categories: A1: 10 patients with suppressed TSH, around 0.01 milli-international unit/liter (mIU/L) A2: 10 patients with TSH values between 0.01 - 0.1 mIU/L A3: 10 patients with TSH values between 0.1 - 0.4 mIU/L |
| Group B: Euthyroid | – | Biological: blood sample30 Patients (under treatment) with TSH values between 0.4 - 4 mIU/L will be included |
| GROUP C: Hypothyroid | – | Biological: blood sample40 patients will be included and divided into two categories: C1: 20 patients with TSH values between 4 - 50 mIU/L C2: 20 patients with TSH values > 50 mIU/L up to 100 mIU/L. Even distribution (if possible). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The recruitment will be performed from the clinical cohort of thyroid disorder patients followed at the Hospices Civils de Lyon Hospital.
Key inclusion criteria (4 listed)
- Male or female ≥ 18 years of age
- Body weight ≥ 62 kg
- With a thyroid disorder (with high, low or normal TSH levels)
- Competent to give non opposition after information
Key exclusion criteria (5 listed)
- Age <18 years old
- Those individuals previously enrolled into this clinical study
- Individuals diagnosed with a severe non-thyroidal illness at physician's appreciation. Defined as a state of dysregulation where levels of T3, T4, free triiodothyronine (FT3) and/or free thyroxine (FT4) are abnormal although the Thyroid gland does not appear to be dysfunctional. In practice, non-thyroidal illness (NTI) is reported to be usually associated with critical illness or starvation. Examples: chronic renal failure, liver cirrhosis, advanced (active) malignancy, sepsis, trauma, prolonged fasting or starvation, heart failure, Myocardial infarction (MI), and any psychiatric disorder.
- Pregnancy - please note that pregnancy test is not needed, a declaration is sufficient. The inclusion of a sample from a woman with an unidentified pregnancy will not jeopardize the study.
- Patient under guardianship and under legal protection
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 |
|---|---|---|
| blood sampleIn practice the only intervention of the study is 49 mL extra blood along with the blood draw that is already planned for diagnosis/follow-up | Biological | GROUP C: Hypothyroid, Group A: Hyperthyroid, Group B: Euthyroid |
Primary outcome
Number of subjet included
Time frame: through study completion, an average of 18 months
The primary objective is to collect 100 blood samples that distributed into the followings groups: GROUP A: Hyperthyroid (N = 30) A1: 10 patients with suppressed TSH, around 0.01 mIU/L A2: 10 patients with TSH values between 0.01 - 0.1 mIU/L A3: 10 patients with TSH values between 0.1 - 0.4 mIU/L GROUP B: Euthyroid (N = 30) Patients (under treatment) with TSH values between 0.4 - 4 mIU/L GROUP C: Hypothyroid (N = 40) C1: 20 patients with TSH values between 4 - 50 mIU/L C2: 20 patients with TSH values > 50 mIU/L up to 100 mIU/L.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Disorders and Thyroid Stimulating; Hormone, C, run by Hospices Civils de Lyon at 2 sites in France.
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 4 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: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of subjet included (time frame: through study completion, an average of 18 months). 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 26 Jan 2026.