Trials / Completed
CompletedNCT01738269
Elecsys HE4 Chinese Reference Value Study
A Multi-center Reference Value Study of Elecsys HE4 in Chinese Population
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,351 (actual)
- Sponsor
- Chinese PLA General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Aim of this study is to provide specimens for establishing reference values of HE4 in an apparently healthy Chinese population using the Roche Elecsys HE4 assay tested on variety of Elecsys and cobas brand immunoassay analyzers. This reference range will be compared to population of subjects who have signs and symptoms of various benign and malignant diseases, including ovarian cancer. This reference range will also be compared to the levels of HE4 in individual subjects who have been diagnosed with ovarian cancer and are being followed longitudinally for recurrence or progression of their disease.
Conditions
Timeline
- Start date
- 2012-11-01
- Primary completion
- 2013-05-01
- Completion
- 2013-05-01
- First posted
- 2012-11-30
- Last updated
- 2013-07-31
Locations
9 sites across 1 country: China
Source: ClinicalTrials.gov record NCT01738269. Inclusion in this directory is not an endorsement.