HypothyroidismPhase 4NCT01921452
Study to Verify Clinical Utility of Point-of-Care (POC) Thyroid Stimulating Hormone (TSH) Test Kits as Compared to Third Generation TSH Test Kit
A Phase 4 study testing Quantitative POC TSH Kit, Qualitative POC TSH Kit and Third generation TSH Kit in people with Hypothyroidism, run by Merck KGaA, Darmstadt, Germany at 1 site in China.
Trial summary
This is a Phase 4, single-center, open-label, interventional study, wherein all enrolled subjects will be tested for Thyroid Stimulating Hormone (TSH) by using the quantitative and the qualitative Point-of-Care (POC) TSH test kits and the third generation TSH test kit at the same time. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- Quantitative POC TSH Kit, Qualitative POC TSH Kit and Third generation TSH Kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Feb 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Suspected hypothyroidism subject
- Willing to comply with the trial protocol
- Signed informed consent document
Who cannot join
- Menstrual period, bleeding hemorrhoids, hematuria
- Drinking or taking aspirin within 48 hours
- Subjects with partially or completely restricted consciousness and behavioral ability, who do not have independent decision-making ability.
- Subjects who are unwilling or unable to complete the trial
- Subjects who do not sign informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center Interventional Study to Verify Clinical Utility of the Quantitative and the Qualitative POC TSH Test Kits Compared With the Third Generation TSH Test Kit
This is a Phase 4, single-center, open-label, interventional study, wherein all enrolled subjects will be tested for Thyroid Stimulating Hormone (TSH) by using the quantitative and the qualitative Point-of-Care (POC) TSH test kits and the third generation TSH test kit at the same time.
- Conditions
- Hypothyroidism
- Being tested
- Quantitative POC TSH Kit, Qualitative POC TSH Kit, Third generation TSH Kit
- Keywords
- Hypothyroidism, Third generation TSH kit, Quantitative POC TSH kit, Qualitative POC TSH kit
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative POC TSH KitDevice
A drop (approximately 30 microliter [mcL]) of blood will be taken from subject's fingertip to test TSH quantitatively by using the quantitative POC TSH test kit according to the product specification on Day 1 to Day 5.
Qualitative POC TSH KitDevice
A drop (approximately 30 mcL) of blood will be taken from subject's fingertip to test TSH qualitatively by using the qualitative POC TSH test kit according to the product specification on Day 1 to Day 5.
Third generation TSH KitDevice
One milliliter (mL) of subject's venous blood will be taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit on Day 1 to Day 5.
| Study group | Role | What they receive |
|---|---|---|
| POC TSH Kits + Third Generation TSH Kit | Experimental | Not described Receives: Device: Quantitative POC TSH Kit; Device: Qualitative POC TSH Kit; Device: Third generation TSH Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Positive and Negative TSH Test Result
Measured: Day 1 up to Day 5
Concentration of TSH in Whole Blood
Measured: Day 1 up to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Serono Limited, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921452
- Sponsor's protocol ID
- EMR 200125_507
- Status last verified
- Nov 2014
- First submitted
- 9 Aug 2013
- Last updated
- 25 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wang T, Sheng S, Ruan M, Yan J, Gu J, Jiang Y, Gao Y, Lu H. Clinical Evaluation of the Immune Colloidal Gold Method for Rapid Qualitative and Quantitative Measurement of Thyroid-Stimulating Hormone as an Assay for Hypothyroidism. Adv Ther. 2016 Nov;33(11):2001-2011. doi: 10.1007/s12325-016-0401-y. Epub 2016 Sep 7.
PubMed 27605368
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Interventional Study to Verify Clinical Utility of the Quantitative and the Qualitative POC TSH Test Kits Compared With the Third Generation TSH Test Kit
- ClinicalTrials.gov ID
- NCT01921452
- Acronym / sponsor ID
- EMR 200125_507
- Conditions
- Hypothyroidism
- Keywords
- Hypothyroidism, Third generation TSH kit, Quantitative POC TSH kit, Qualitative POC TSH kit
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 13 Aug 2013 (estimated)
- Results
- Posted 25 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 4, single-center, open-label, interventional study, wherein all enrolled subjects will be tested for Thyroid Stimulating Hormone (TSH) by using the quantitative and the qualitative Point-of-Care (POC) TSH test kits and the third generation TSH test kit at the same time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POC TSH Kits + Third Generation TSH Kit | Experimental | Device: Quantitative POC TSH Kit, Device: Qualitative POC TSH Kit, Device: Third generation TSH Kit |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Suspected hypothyroidism subject
- Willing to comply with the trial protocol
- Signed informed consent document
Key exclusion criteria (5 listed)
- Menstrual period, bleeding hemorrhoids, hematuria
- Drinking or taking aspirin within 48 hours
- Subjects with partially or completely restricted consciousness and behavioral ability, who do not have independent decision-making ability.
- Subjects who are unwilling or unable to complete the trial
- Subjects who do not sign informed consent form
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 |
|---|---|---|
| Quantitative POC TSH KitA drop (approximately 30 microliter [mcL]) of blood will be taken from subject's fingertip to test TSH quantitatively by using the quantitative POC TSH test kit according to the product specification on Day 1 to Day 5. | Device | POC TSH Kits + Third Generation TSH Kit |
| Qualitative POC TSH KitA drop (approximately 30 mcL) of blood will be taken from subject's fingertip to test TSH qualitatively by using the qualitative POC TSH test kit according to the product specification on Day 1 to Day 5. | Device | POC TSH Kits + Third Generation TSH Kit |
| Third generation TSH KitOne milliliter (mL) of subject's venous blood will be taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit on Day 1 to Day 5. | Device | POC TSH Kits + Third Generation TSH Kit |
Primary outcome
Number of Participants With Positive and Negative TSH Test Result
Time frame: Day 1 up to Day 5
Concentration of TSH in Whole Blood
Time frame: Day 1 up to Day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27605368Wang T, Sheng S, Ruan M, Yan J, Gu J, Jiang Y, Gao Y, Lu H. Clinical Evaluation of the Immune Colloidal Gold Method for Rapid Qualitative and Quantitative Measurement of Thyroid-Stimulating Hormone as an Assay for Hypothyroidism. Adv Ther. 2016 Nov;33(11):2001-2011. doi: 10.1007/s12325-016-0401-y. Epub 2016 Sep 7.
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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.
Medical Responsible study director
Merck Serono Limited, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quantitative POC TSH Kit, Qualitative POC TSH Kit and Third generation TSH Kit in people with Hypothyroidism, run by Merck KGaA, Darmstadt, Germany at 1 site in China.
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 3 inclusion and 5 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 25 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Positive and Negative TSH Test Result (time frame: Day 1 up to Day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01921452, which also lists 1 linked publication.
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 25 Nov 2014.