Condition or disease |
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Healthy |
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.
Study Type : | Observational |
Actual Enrollment : | 137 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | 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 |
Actual Study Start Date : | April 25, 2018 |
Actual Primary Completion Date : | July 18, 2018 |
Actual Study Completion Date : | August 29, 2018 |
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Current diagnosis of a serious health condition that involves inpatient care or continuing treatment by a health care provider, such as:
Canada, British Columbia | |
Response Biomedical Corp. | |
Vancouver, British Columbia, Canada, V6P 6P2 |
Tracking Information | |||||
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First Submitted Date | March 26, 2018 | ||||
First Posted Date | April 2, 2018 | ||||
Last Update Posted Date | January 25, 2019 | ||||
Actual Study Start Date | April 25, 2018 | ||||
Actual Primary Completion Date | July 18, 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Measurement of blood hCG level. [ Time Frame: baseline ] Measurement of hCG in a single EDTA blood sample from healthy, non-pregnant adult female subjects using the RAMP Total β-hCG test.
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Original Primary Outcome Measures |
Determination of URL of the RAMP Total β-hCG test in a healthy, non-pregnant, adult female reference population. [ Time Frame: Single visit/sample per subject ] The 95th percentile of RAMP Total β-hCG test results from testing a single EDTA blood sample from each subject will be determined for subjects 18-40 and >40 years of age.
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Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Beta-hCG Test Reference Range Determination | ||||
Official Title | 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 | ||||
Brief 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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples Without DNA Description:
EDTA blood samples will be processed into plasma and stored frozen for study duration.
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Sampling Method | Non-Probability Sample | ||||
Study Population | Approximately two hundred-fifty (250) healthy, non-pregnant adult female subjects will be enrolled in the 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.There are no enrollment restrictions based upon race or ethnic origin. | ||||
Condition | Healthy | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Terminated | ||||
Actual Enrollment |
137 | ||||
Original Estimated Enrollment |
250 | ||||
Actual Study Completion Date | August 29, 2018 | ||||
Actual Primary Completion Date | July 18, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Canada | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03485313 | ||||
Other Study ID Numbers | CSP027 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Response Biomedical Corp. | ||||
Study Sponsor | Response Biomedical Corp. | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | Response Biomedical Corp. | ||||
Verification Date | January 2019 |