Validation of a New TSH Test

Not Applicable

Completed

• Conditions: Hypothyroidism; Euthyroidism; Sub-clinical Hypothyroidism
• Interventions: Other: Blood sample

• Registration Number: NCT01997554
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-10-28
• Study First Submitted QC: 2013-11-27
• Study First Posted: 2013-11-28
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-09
• Last Update Submitted: 2019-06-28
• Last Update Posted: 2019-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1654

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
less than 60 years old with clinical symptom of hypothyroidism	Blood sample	Group of patients less than 60 years old, with at least one clinical symptom of hypothyroidism
less than 60 years old without clinical symptoms	Blood sample	Group of patients less than 60 years old, without clinical symptoms of hypothyroidism
more than 60 years old	Blood sample	Group of patients more than 60 years old at recruitment.

Primary Outcome Measures

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

Trial Locations

Locations (2)

Centre Hospitalier de Chambéry; 🇫🇷 Chambéry, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France