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TerminatedNCT03485313Updated Jan 25, 2019

Beta-hCG Test Reference Range Determination

An observational study in Healthy, sponsored by Response Biomedical Corp.. Terminated at 1 site in Canada. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-25.

Sponsored by Response Biomedical Corp. · Observational

Why this study was terminated
Study stopped due to slow enrollment; sufficient data collected for analysis.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
137
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • Healthy
  • Volunteer
  • Female
  • Pregnancy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

Inclusion criteria

  1. Apparently healthy, non-pregnant females, of any race.
  2. >18 years of age.
  3. Willing to voluntarily agree to sign a consent form.

Exclusion criteria

Exclusion Criteria:

  1. Current pregnancy, suspected pregnancy, or pregnancy within previous 12 months.
  2. Currently lactating/nursing a child.
  3. Current diagnosis of Gestational Trophoblastic Disease, Gestational Trophoblastic Tumor or Gestational Trophoblastic Neoplasia.
  4. Current diagnosis of non-trophoblastic tumors.
  5. Current diagnosis of cancer and/or has undergone immunotherapy in the previous 12 months.

  6. 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).
  7. Hospitalization (for >24 hours) or major surgery within previous 3 months.
  8. Unable, or unwilling, to provide required blood sample for testing.
  9. 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).
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
137 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
05

What researchers measure

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.

    Time frame: baseline

06

Study locations

1 site
  • Response Biomedical Corp.
    Vancouver, British Columbia V6P 6P2, Canada
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03485313
Lead sponsor
Response Biomedical Corp.
Responsible party
Sponsor
First posted
Apr 2, 2018
Start date
Apr 25, 2018
Primary completion
Jul 18, 2018
Completion
Aug 29, 2018
Last update
Jan 25, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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