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

• Sponsor: Merck KGaA, Darmstadt, Germany (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01921452
• Collaborator: (none)
• Enrollment: 283
• Location: 1
• Arm: 1
• Duration (Months): 4
• Patients Per Site Per Month: 70

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypothyroidism	Device: Quantitative POC TSH Kit; Device: Qualitative POC TSH Kit; Device: Third generation TSH Kit	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 283 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Feb 1, 2014

Arms and Interventions

Arm

Intervention/Treatment

Experimental: POC TSH Kits + Third Generation TSH Kit

Device: 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.; 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.; 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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Positive and Negative TSH Test Result [Day 1 up to Day 5]

2. Concentration of TSH in Whole Blood [Day 1 up to Day 5]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research site	Shanghai		China

Sponsors and Collaborators

• Merck KGaA, Darmstadt, Germany

Investigators

• Study Director: Medical Responsible, Merck Serono Co. Ltd. an affiliate of Merck KGaA, Darmstadt, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merck KGaA, Darmstadt, Germany
• ClinicalTrials.gov Identifier: NCT01921452
• Other Study ID Numbers: EMR 200125_507
• First Posted: Aug 13, 2013
• Last Update Posted: Nov 25, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by Merck KGaA, Darmstadt, Germany: Hypothyroidism; Third generation TSH kit; Quantitative POC TSH kit; Qualitative POC TSH kit
• Additional relevant MeSH terms: Hypothyroidism

Study Results

Participant Flow

Pre-assignment Detail	All 283 enrolled participants were analyzed using both point-of-care (POC) thyroid stimulating hormone (TSH) kits and third generation TSH kit.

Arm/Group Title	POC TSH Kits + Third Generation Kit
Arm/Group Description	Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant's fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
Period Title: Overall Study
STARTED	283
COMPLETED	283
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	POC TSH Kits + Third Generation TSH Kit
Arm/Group Description	Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant's fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
Overall Participants	283
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	42.99 (12.52)
Sex: Female, Male (Count of Participants)
Female	181 64%
Male	102 36%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Positive and Negative TSH Test Result
Time Frame	Day 1 up to Day 5

Outcome Measure Data

Analysis Population Description

The FAS included all enrolled participants. 'n' signifies number of participants who were evaluable for this measure for the specified category.

Arm/Group Title	POC TSH Kits + Third Generation TSH Kit
Arm/Group Description	Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant's fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
Measure Participants	283
POC TSH kits (Positive) (n=282)	103 36.4%
POC TSH kits (Negative) (n=282)	179 63.3%
Third generation kit (Positive) (n=283)	121 42.8%
Third generation kit (Negative) (n=283)	162 57.2%

2. Primary Outcome

Title	Concentration of TSH in Whole Blood
Time Frame	Day 1 up to Day 5

Outcome Measure Data

Analysis Population Description

The FAS included all enrolled participants.

Arm/Group Title	POC TSH Kits + Third Generation Kit
Arm/Group Description	Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant's fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
Measure Participants	283
POC TSH kits	7.38 (8.49)
Third generation kit	30.18 (41.94)

Adverse Events

Time Frame	Day 1 up to Day 5
Adverse Event Reporting Description	Safety analysis set included all participants whose blood was collected.
Arm/Group Title	POC TSH Kit + Third Generation TSH Kit
Arm/Group Description	Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant's fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
All Cause Mortality
	POC TSH Kit + Third Generation TSH Kit
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	POC TSH Kit + Third Generation TSH Kit
	Affected / at Risk (%)	# Events
Total	0/283 (0%)
Other (Not Including Serious) Adverse Events
	POC TSH Kit + Third Generation TSH Kit
	Affected / at Risk (%)	# Events
Total	0/283 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The disclosure restriction on the PI is that the sponsor can review the results communications prior to public release, and the sponsor can embargo communications regarding trial results if the PI does not get approval from the sponsor.