Validation of a New TSH Test

Civil Hospices of Lyon

Status: Completed

Conditions: Euthyroidism; Hypothyroidism; Sub-clinical Hypothyroidism

Treatments: Other: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT01997554

2011.672

Details and patient eligibility

About

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.

Enrollment: 1,654 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,654 participants in 3 patient groups

less than 60 years old with clinical symptom of hypothyroidism

Experimental group

Description:

Group of patients less than 60 years old, with at least one clinical symptom of hypothyroidism

Treatment:

Other: Blood sample

less than 60 years old without clinical symptoms

Experimental group

Description:

Group of patients less than 60 years old, without clinical symptoms of hypothyroidism

Treatment:

Other: Blood sample

more than 60 years old

Experimental group

Description:

Group of patients more than 60 years old at recruitment.

Treatment:

Other: Blood sample