NCT01921452

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
283

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
10 months until next milestone

Results Posted

Study results publicly available

November 25, 2014

Completed
Last Updated

November 25, 2014

Status Verified

November 1, 2014

Enrollment Period

4 months

First QC Date

August 9, 2013

Results QC Date

November 20, 2014

Last Update Submit

November 20, 2014

Conditions

Hypothyroidism

Keywords

HypothyroidismThird generation TSH kitQuantitative POC TSH kitQualitative POC TSH kit

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Positive and Negative TSH Test Result

    Day 1 up to Day 5

  • Concentration of TSH in Whole Blood

    Day 1 up to Day 5

Study Arms (1)

POC TSH Kits + Third Generation TSH Kit

EXPERIMENTAL
Device: Quantitative POC TSH KitDevice: Qualitative POC TSH KitDevice: Third generation TSH Kit

Interventions

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.

POC TSH Kits + Third Generation TSH Kit
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.

POC TSH Kits + Third Generation TSH Kit
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.

POC TSH Kits + Third Generation TSH Kit

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research site

Shanghai, China

Location

Related Publications (1)

  • 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.

    PMID: 27605368DERIVED

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Results Point of Contact

Title
Merck KGaA Communication Center
Organization
Merck Serono, a division of Merck KGaA
service@merckgroup.com
49-6151-72-5200

Study Officials

  • Medical Responsible

    Merck Serono Limited, UK

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2013

First Posted

August 13, 2013

Study Start

October 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

November 25, 2014

Results First Posted

November 25, 2014

Record last verified: 2014-11

Locations

CN(1)