Validation of a New TSH Test

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.

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Key information

Conditions

Sub-clinical Hypothyroidism Endocrine System Diseases Euthyroidism Hypothyroidism Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de Chambéry, Chambéry, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects more than 18 years old
Thyroid test planned in the normal health care of patients
Subject who has been informed about "TSH Testing" study with a complete Subject Information Sheet and who has signed a consent form
Subject covered by the Health Social System

Exclusion criteria

Subjects with hyperthyroidism (clinical symptoms : weight loss with unaltered appetite, palpitations in the absence of cardio-vascular pathology, unusual and recent nervousness)
Subject not covered by the Health Social System
Subject who already participates to another clinical research study, which might interfere with TSH Testing Study
Pregnant, parturient or breastfeeding mother
Person deprived of freedom by a judicial or administrative decision
Person under a legal guardianship or unable to consent (MMSE score < 20/30 for the patients for whom this test has been performed).

Treatment and study plan

blood sample

Other

An extra blood sample of 10 ml is collected

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)

Time frame: Recruitment period : 30 months (starting from February 2012) in order to establish a serum bank
- Measurement of sensibility and specificity and determination of the cut-off value of the new TSH test proposed by Siamed'Xpress
- Study of the association between TSH measurements obtained with the different techniques (IRMA vs new technique proposed by Siamed'Xpress)
- Study of the concordance of the different diagnostic tests for hypothyroidism detection

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Validation of a New TSH Test for Early Screening of Hypothyroidism

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Nov 28, 2013
Registry last updated: Jul 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed