Status:
TERMINATED
Beta-hCG Test Reference Range Determination
Lead Sponsor:
Response Biomedical Corp.
Conditions:
Healthy
Eligibility:
FEMALE
18+ years
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® Tot...
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 concentratio...
Eligibility Criteria
Inclusion
- Apparently healthy, non-pregnant females, of any race.
- \>18 years of age.
- Willing to voluntarily agree to sign a consent form.
Exclusion
- Current pregnancy, suspected pregnancy, or pregnancy within previous 12 months.
- Currently lactating/nursing a child.
- Current diagnosis of Gestational Trophoblastic Disease, Gestational Trophoblastic Tumor or Gestational Trophoblastic Neoplasia.
- Current diagnosis of non-trophoblastic tumors.
- Current diagnosis of cancer and/or has undergone immunotherapy in the previous 12 months.
- Current diagnosis of a serious health condition that involves inpatient care or continuing treatment by a health care provider, such as:
- Conditions or treatments that result in continuous or episodic incapacity (e.g. pneumonia, epilepsy).
- Permanent or long-term conditions (e.g. HIV, Alzheimer's, severe stroke).
- Conditions requiring multiple treatment/recovery cycles (e.g. kidney disease).
- Hospitalization (for \>24 hours) or major surgery within previous 3 months.
- Unable, or unwilling, to provide required blood sample for testing.
- Investigator believes subject is unsuitable for inclusion in the trial (i.e. has serious condition(s) or other reason(s) that could limit their ability to participate in the study; or impact the scientific integrity of the study).
Key Trial Info
Start Date :
April 25 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 29 2018
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT03485313
Start Date
April 25 2018
End Date
August 29 2018
Last Update
January 25 2019
Active Locations (1)
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1
Response Biomedical Corp.
Vancouver, British Columbia, Canada, V6P 6P2