Validation of a New TSH Test

Hypothyroidism Clinical Trial

Official title:

Validation of a New TSH Test for Early Screening of Hypothyroidism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997554
• Other study ID #: 2011.672
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1654
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Euthyroidism
• Hypothyroidism
• Sub-clinical Hypothyroidism

Intervention

Other:
• Blood sample
An extra blood sample of 10 ml is collected

Locations

Country	Name	City	State
France	Centre Hospitalier de Chambéry	Chambéry
France	Centre Hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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	Recruitment period : 30 months (starting from February 2012) in order to establish a serum bank

External Links

•   Study results