Trials / Terminated
TerminatedNCT03485313
Beta-hCG Test Reference Range Determination
Clinical Evaluation to Determine the Expected Values Distribution of β-hCG for the RAMP® Total β-hCG Test in a Healthy, Non-pregnant Reference Population
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 137 (actual)
- Sponsor
- Response Biomedical Corp. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Prospective, single-centre study to determine the reference range (95th percentile) of human chorionic gonadotropin (hCG) levels in a healthy, non-pregnant, adult female population using the RAMP® Total β-hCG test.
Detailed description
Human chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by the placenta shortly after implantation of a fertilized ovum into the uterine wall and the rapid rise of blood hCG concentration after conception makes it an excellent marker for confirmation and monitoring of early pregnancy. As such, levels in the blood of non-pregnant premenopausal individuals are low, typically \< 5 mIU/mL (milli-International Unit per milliliter). In terms of identifying a clinically significant range of expected hCG values as determined by the RAMP β-hCG test, a 95th percentile of a healthy, non-pregnant, adult female reference population \[upper reference limit (URL)\] shall be determined in this study. Subjects who meet the inclusion and exclusion criteria, and give informed consent will be enrolled in this study. Because hCG levels in blood increase with age, the study population will be divided into two age groups: 18 to 40 years and \>40 years, with approximately 125 subjects per group. One EDTA (ethylenediaminetetraacetic acid) blood sample will be collected from each subject via standard venipuncture. The maximum trial duration for each subject will be one visit/blood draw.
Conditions
Timeline
- Start date
- 2018-04-25
- Primary completion
- 2018-07-18
- Completion
- 2018-08-29
- First posted
- 2018-04-02
- Last updated
- 2019-01-25
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT03485313. Inclusion in this directory is not an endorsement.