NCT01997554

Validation of a New TSH Test

Validation of a New TSH Test for Early Screening of Hypothyroidism

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,654 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sub-clinical Hypothyroidism
• Hypothyroidism
• Euthyroidism

Interventions

Type	Name	Description
OTHER	Blood sample	An extra blood sample of 10 ml is collected

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-11-28
• Last updated: 2019-07-01

Locations

2 sites across 1 country: France