Validation of a New TSH Test

NCT ID: NCT01997554

Last Updated: 2019-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1654 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sub-clinical Hypothyroidism Hypothyroidism Euthyroidism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Blood sample

Intervention Type OTHER

An extra blood sample of 10 ml is collected

less than 60 years old without clinical symptoms

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

Group Type EXPERIMENTAL

Blood sample

Intervention Type OTHER

An extra blood sample of 10 ml is collected

more than 60 years old

Group of patients more than 60 years old at recruitment.

Group Type EXPERIMENTAL

Blood sample

Intervention Type OTHER

An extra blood sample of 10 ml is collected

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood sample

An extra blood sample of 10 ml is collected

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Hospitalier de Chambéry

Chambéry, , France

Site Status

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011.672

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Recurrent Pregnancy Loss and Thyroid Disease
NCT03106935 UNKNOWN EARLY_PHASE1