Harmonization of Thyroid-stimulating Hormone Immunoassays Reagents

Recruiting

• Conditions: Thyroid Stimulating; Hormone, C; Thyroid Disorders
• Interventions: Biological: blood sample

• Registration Number: NCT05151120
• Lead Sponsor: Hospices Civils de Lyon

Brief 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. 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-11-25
• Study First Posted: 2021-12-09
• Study Start: 2022-05-05
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-19
• Last Update Posted: 2023-10-23
• Primary Completion: 2026-05-05
• Study Completion: 2026-05-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GROUP C: Hypothyroid	blood sample	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).
Group A: Hyperthyroid	blood sample	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
Group B: Euthyroid	blood sample	30 Patients (under treatment) with TSH values between 0.4 - 4 mIU/L will be included

Primary Outcome Measures

Name	Time	Method
Number of subjet included	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.

Trial Locations

Locations (2)

Service de Médecine Nucléaire - Hôpital Louis Pradel - Hospices Civils de Lyon; 🇫🇷 Bron, France

Service D'endocrinologie - Hôpital Louis Pradel - Hospices Civils de Lyon; 🇫🇷 Bron, France