Harmonization of Thyroid-stimulating Hormone Immunoassays Reagents

Launched by HOSPICES CIVILS DE LYON · Nov 25, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how to improve the measurement of thyroid-stimulating hormone (TSH) in blood tests. TSH levels are crucial for diagnosing and managing thyroid disorders, which can significantly impact a person's health. The trial aims to harmonize the different ways labs measure TSH, so that results are consistent and comparable, no matter where a patient gets tested. This is especially important for patients who see multiple doctors or travel to different countries, as varying test results can be confusing and hinder effective treatment.

To participate in the trial, individuals must be at least 18 years old, weigh at least 62 kg, and have a thyroid disorder, which means their TSH levels may be high, low, or normal. Participants will provide blood samples that will help researchers establish a common reference for TSH measurements across labs. It's important to note that this study is not open to individuals under 18, those with certain severe illnesses, or pregnant women. By joining this trial, participants can contribute to better thyroid health care for everyone.

Gender

ALL

Eligibility criteria

• 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