Beta-hCG Test Reference Range Determination

NCT03485313 | Terminated

• 1 other identifier: CSP027
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy; Volunteer; Female; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Measurement of blood hCG level.

  Measurement of hCG in a single EDTA blood sample from healthy, non-pregnant adult female subjects using the RAMP Total β-hCG test.

  baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Apparently healthy, non-pregnant females, of any race.
• \>18 years of age.
• Willing to voluntarily agree to sign a consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Response Biomedical Corp.: lead

Study Sites (1)

Response Biomedical Corp.

Vancouver, British Columbia, V6P 6P2, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

EDTA blood samples will be processed into plasma and stored frozen for study duration.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 2, 2018
• Study Start: April 25, 2018
• Primary Completion: July 18, 2018
• Study Completion: August 29, 2018
• Last Updated: January 25, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)