Harmonizing thyroid hormone test results

Harmonization of Thyroid-stimulating Hormone Immunoassays Reagents - Blood Collection From Patients With Thyroid Disorders

This study is trying to find a standard way to measure thyroid hormone levels in blood tests for adults with thyroid disorders to make sure everyone gets accurate diagnoses and treatments.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospices Civils de Lyon (other)
• Locations: 2 sites (Bron and 1 other locations)
• Trial ID: NCT05151120 on ClinicalTrials.gov

What this trial studies

This observational study aims to address the challenges posed by varying reference intervals (RIs) for thyroid-stimulating hormone (TSH) tests across different laboratories. By collecting blood samples from individuals with thyroid disorders, the study seeks to establish common RIs that can be used universally, thereby improving the accuracy of diagnosis and treatment. The focus is on ensuring that TSH measurements are comparable, which is crucial for effective clinical management and public health standards. The study will involve participants aged 18 and older who have been diagnosed with thyroid disorders.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with diagnosed thyroid disorders, regardless of their TSH levels.

Not a fit: Patients under 18 years old or those with severe non-thyroidal illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate and consistent diagnosis and management of thyroid disorders across different healthcare settings.

How similar studies have performed: While the approach of harmonizing TSH test results is not widely tested, the need for standardized reference intervals has been recognized in other studies, indicating potential for success.

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

Where this trial is running

Bron and 1 other locations

• Service D'endocrinologie - Hôpital Louis Pradel - Hospices Civils de Lyon — Bron, France (RECRUITING)
• Service de Médecine Nucléaire - Hôpital Louis Pradel - Hospices Civils de Lyon — Bron, France (RECRUITING)

Study contacts

• Study coordinator: RAVEROT Véronique, MD

Conditions: Thyroid Disorders, Thyroid Stimulating, Hormone, C, Blood Sample collection, TSH results harmonisation, IVD-manufacturers, Reference intervals, Results harmonisation