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Validation of a New TSH Test

Primary Purpose

Sub-clinical Hypothyroidism, Hypothyroidism, Euthyroidism

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sub-clinical Hypothyroidism focused on measuring TSH Testing, sub-clinical hypothyroidism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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).

Sites / Locations

  • Centre Hospitalier de Chambéry
  • Centre Hospitalier Lyon Sud

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

less than 60 years old with clinical symptom of hypothyroidism

less than 60 years old without clinical symptoms

more than 60 years old

Arm Description

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

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

Group of patients more than 60 years old at recruitment.

Outcomes

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)
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

Secondary Outcome Measures

Full Information

First Posted
October 28, 2013
Last Updated
June 28, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01997554
Brief Title
Validation of a New TSH Test
Official Title
Validation of a New TSH Test for Early Screening of Hypothyroidism
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (Actual)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sub-clinical Hypothyroidism, Hypothyroidism, Euthyroidism
Keywords
TSH Testing, sub-clinical hypothyroidism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1654 (Actual)

8. Arms, Groups, and Interventions

Arm Title
less than 60 years old with clinical symptom of hypothyroidism
Arm Type
Experimental
Arm Description
Group of patients less than 60 years old, with at least one clinical symptom of hypothyroidism
Arm Title
less than 60 years old without clinical symptoms
Arm Type
Experimental
Arm Description
Group of patients less than 60 years old, without clinical symptoms of hypothyroidism
Arm Title
more than 60 years old
Arm Type
Experimental
Arm Description
Group of patients more than 60 years old at recruitment.
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
An extra blood sample of 10 ml is collected
Primary Outcome Measure Information:
Title
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)
Description
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
Time Frame
Recruitment period : 30 months (starting from February 2012) in order to establish a serum bank

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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).
Facility Information:
Facility Name
Centre Hospitalier de Chambéry
City
Chambéry
ZIP/Postal Code
73000
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France

12. IPD Sharing Statement

Links:
URL
https://www.omicsonline.org/open-access/new-immunoassays-of-bioactive-tsh-improve-detection-of-thyroid-disorders-2167-7948-1000223-95186.html
Description
Study results

Learn more about this trial

Validation of a New TSH Test

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