Validation of a New TSH Test

N/ACompletedNCT01997554

Hospices Civils de Lyon1,654 enrolled

Overview

The aim of this research project, which is realised with the partnership of the enterprise Siamed'Xpress (Marseille), is to validate a new TSH diagnostic test in vitro, to allow an earlier screening of hypothyroidism. A serum bank will be conserved in the "Centre de Biologie Sud" ("Groupement Hospitalier Lyon Sud"). The serum samples will be assayed locally for the usual medical support to patients and after they will be sent to Siamed'Xpress (Marseille), where they will be assayed with the new diagnostic test. The results obtained from the two techniques will be compared. The validation of this new TSH test represents a major advancement, since it could bring in the future to a therapeutic index which will allow clinicians to treat earlier asymptomatic patients with subclinical hypothyroidism.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

1,654

Conditions

Sub-clinical Hypothyroidism Hypothyroidism Euthyroidism

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects more than 18 years old 2. Thyroid test planned in the normal health care of patients 3. Subject who has been informed about "TSH Testing" study with a complete Subject Information Sheet and who has signed a consent form 4. Subject covered by the Health Social System Exclusion Criteria: 1. Subjects with hyperthyroidism (clinical symptoms : weight loss with unaltered appetite, palpitations in the absence of cardio-vascular pathology, unusual and recent nervousness) 2. Subject not covered by the Health Social System 3. Subject who already participates to another clinical research study, which might interfere with TSH Testing Study 4. Pregnant, parturient or breastfeeding mother 5. Person deprived of freedom by a judicial or administrative decision 6. Person under a legal guardianship or unable to consent (MMSE score \< 20/30 for the patients for whom this test has been performed).

Outcomes

Primary Outcomes

TSH assay of all the patients samples conserved in the serum bank with two techniques: technique IRMA (Immuno Radiometric Assay) and the new technique developed by Siamed'Xpress (Marseille)

1. Measurement of sensibility and specificity and determination of the cut-off value of the new TSH test proposed by Siamed'Xpress 2. Study of the association between TSH measurements obtained with the different techniques (IRMA vs new technique proposed by Siamed'Xpress) 3. Study of the concordance of the different diagnostic tests for hypothyroidism detection

Time frame: Recruitment period : 30 months (starting from February 2012) in order to establish a serum bank