Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1654 participants
INTERVENTIONAL
2012-03-31
2014-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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
Blood sample
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
Blood sample
An extra blood sample of 10 ml is collected
more than 60 years old
Group of patients more than 60 years old at recruitment.
Blood sample
An extra blood sample of 10 ml is collected
Interventions
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Blood sample
An extra blood sample of 10 ml is collected
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
Yes
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Centre Hospitalier de Chambéry
Chambéry, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Countries
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Related Links
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Other Identifiers
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2011.672
Identifier Type: -
Identifier Source: org_study_id
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