Validation of a New TSH Test

June 28, 2019 updated by: Hospices Civils de Lyon

Validation of a New TSH Test for Early Screening of Hypothyroidism

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1654

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Chambéry, France, 73000
        • Centre Hospitalier de Chambery
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: less than 60 years old with clinical symptom of hypothyroidism
Group of patients less than 60 years old, with at least one clinical symptom of hypothyroidism
Other: Blood sample
An extra blood sample of 10 ml is collected
Experimental: less than 60 years old without clinical symptoms
Group of patients less than 60 years old, without clinical symptoms of hypothyroidism
Other: Blood sample
An extra blood sample of 10 ml is collected
Experimental: more than 60 years old
Group of patients more than 60 years old at recruitment.
Other: Blood sample
An extra blood sample of 10 ml is collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
  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
Recruitment period : 30 months (starting from February 2012) in order to establish a serum bank

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

October 28, 2013

First Submitted That Met QC Criteria

November 27, 2013

First Posted (Estimate)

November 28, 2013

Study Record Updates

Last Update Posted (Actual)

July 1, 2019

Last Update Submitted That Met QC Criteria

June 28, 2019

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011.672

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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