Sub-clinical HypothyroidismNCT01997554
Validation of a New TSH Test
A study testing Blood sample in people with Sub-clinical Hypothyroidism and Hypothyroidism, run by Hospices Civils de Lyon at 2 sites in France.
Trial 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"). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sub-clinical Hypothyroidism, Hypothyroidism, Euthyroidism
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,654 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2012to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier de Chambéry
Chambéry, 73000
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
About this study
Official title: Validation of a New TSH Test for Early Screening of Hypothyroidism
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
- Being tested
- Blood sample
- Keywords
- TSH Testing, sub-clinical hypothyroidism
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
An extra blood sample of 10 ml is collected
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Blood sample |
| more than 60 years old | Experimental | Group of patients more than 60 years old at recruitment. Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Recruitment period : 30 months (starting from February 2012) in order to establish a serum bank
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startMar 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sub-clinical HypothyroidismStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,654 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997554
- Sponsor's protocol ID
- 2011.672
- Status last verified
- Sep 2014
- First submitted
- 28 Oct 2013
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a New TSH Test for Early Screening of Hypothyroidism
- ClinicalTrials.gov ID
- NCT01997554
- Acronym / sponsor ID
- 2011.672
- Conditions
- Sub-clinical Hypothyroidism, Hypothyroidism, Euthyroidism
- Keywords
- TSH Testing, sub-clinical hypothyroidism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,654 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| less than 60 years old with clinical symptom of hypothyroidism | Experimental | Other: Blood sampleGroup of patients less than 60 years old, with at least one clinical symptom of hypothyroidism |
| less than 60 years old without clinical symptoms | Experimental | Other: Blood sampleGroup of patients less than 60 years old, without clinical symptoms of hypothyroidism |
| more than 60 years old | Experimental | Other: Blood sampleGroup of patients more than 60 years old at recruitment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleAn extra blood sample of 10 ml is collected | Other | less than 60 years old with clinical symptom of hypothyroidism, less than 60 years old without clinical symptoms, more than 60 years old |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
- Study resultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Sub-clinical Hypothyroidism and Hypothyroidism, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2019.