Validation of a New TSH Test

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01997554
First received: October 28, 2013
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Sub-clinical Hypothyroidism
Hypothyroidism
Euthyroidism
Other: Blood sample

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Validation of a New TSH Test for Early Screening of Hypothyroidism

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Enrollment: 1654
Study Start Date: March 2012
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01997554

Locations
France
Centre Hospitalier de Chambéry
Chambéry, France, 73000
Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01997554     History of Changes
Other Study ID Numbers: 2011.672
Study First Received: October 28, 2013
Last Updated: September 11, 2014
Health Authority: France: Direction Générale de la Santé

Keywords provided by Hospices Civils de Lyon:
TSH Testing
sub-clinical hypothyroidism

Additional relevant MeSH terms:
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014