Harmonization of Thyroid-stimulating Hormone Immunoassays Reagents (IFCC-TSH)

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.

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 Overview

• Status: Recruiting
• Conditions: Thyroid Disorders; Thyroid Stimulating; Hormone, C
• Intervention / Treatment: Biological: blood sample

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: RAVEROT Véronique, MD; Phone Number: +33 04.72.35.74.61; Email: veronique.raverot@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69 677
    • Recruiting
    • Service D'endocrinologie - Hôpital Louis Pradel - Hospices Civils de Lyon
    • Contact: ABEILLON Juliette, MD; Phone Number: +33 04 72 11 93 01; Email: juliette.abeillon@chu-lyon.fr
    • Principal Investigator: ABEILLON Juliette, MD
  • Bron, France, 69 677
    • Recruiting
    • Service de Médecine Nucléaire - Hôpital Louis Pradel - Hospices Civils de Lyon
    • Contact: JANIER Marc, MD, PhD; Phone Number: +33 04.72.11.02.50; Email: marc.janier@chu-lyon.fr
    • Principal Investigator: JANIER Marc, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The recruitment will be performed from the clinical cohort of thyroid disorder patients followed at the Hospices Civils de Lyon Hospital.

Description

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

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Biological: blood sample; 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
Group B: Euthyroid; 30 Patients (under treatment) with TSH values between 0.4 - 4 mIU/L will be included	Biological: blood sample; 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
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).	Biological: blood sample; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	through study completion, an average of 18 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2022
• Primary Completion (Estimated): May 5, 2026
• Study Completion (Estimated): May 5, 2026

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Blood Sample collection; TSH results harmonisation; IVD-manufacturers; Reference intervals; Results harmonisation
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: 69HCL21_0806; 2021-A02187-34 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No