MedDataX Logo

Study to Verify Clinical Utility of Point-of-Care (POC) Thyroid Stimulating Hormone (TSH) Test Kits as Compared to Third Generation TSH Test Kit

NCT ID: NCT01921452

Last Updated: 2014-11-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

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

PHASE4

Total Enrollment

283 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-02-28

Brief Summary

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

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.

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.

Hypothyroidism

Study Design

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

Allocation Method

NA

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.

POC TSH Kits + Third Generation TSH Kit

Group Type EXPERIMENTAL

Quantitative POC TSH Kit

Intervention Type DEVICE

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 Kit

Intervention Type DEVICE

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 Kit

Intervention Type DEVICE

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.

Interventions

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

Quantitative POC TSH Kit

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.

Intervention Type DEVICE

Qualitative POC TSH Kit

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.

Intervention Type DEVICE

Third generation TSH Kit

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.

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Suspected hypothyroidism subject
* Willing to comply with the trial protocol
* Signed informed consent document

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role lead

Responsible Party

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

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Responsible

Role: STUDY_DIRECTOR

Merck Serono Limited, UK

Locations

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

Research site

Shanghai, , China

Site Status

Countries

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

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 27605368 (View on PubMed)

Other Identifiers

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

EMR 200125_507

Identifier Type: -

Identifier Source: org_study_id