Validation of a New TSH Test

NCT01997554 | Completed

• 1 other identifier: 2011.672
• Study Type: interventional
• Target: 1,654
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

TSH Testing; sub-clinical hypothyroidism

Outcome Measures

Primary Outcomes (1)

• 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)

  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

Study Arms (3)

less than 60 years old with clinical symptom of hypothyroidism

EXPERIMENTAL

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

Other: Blood sample

less than 60 years old without clinical symptoms

EXPERIMENTAL

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

Other: Blood sample

more than 60 years old

EXPERIMENTAL

Group of patients more than 60 years old at recruitment.

Other: Blood sample

Interventions

Blood sample OTHER

An extra blood sample of 10 ml is collected

less than 60 years old with clinical symptom of hypothyroidism; less than 60 years old without clinical symptoms; more than 60 years old

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Centre Hospitalier de Chambéry

Chambéry, 73000, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Related Links

• Study results

MeSH Terms

Conditions

Hypothyroidism

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 28, 2013
• Study Start: March 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: July 1, 2019

Record last verified: 2014-09

Locations

FR (2)