A Multi-center Reference Value Study of Elecsys HE4 in Chinese Population
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Ovarian Cancer
Both
Ovarian Cancer
Trial Information
A Multi-center Reference Value Study of Elecsys HE4 in Chinese Population
Inclusion Criteria
Inclusion Criteria (all cohorts):
- appropriate clinical data
- normal appearance of sample
- minimum 0.5 ml volume available
Exclusion Criteria (all cohorts):
- < 18 years of age
- insufficient volume
- insufficient clinical information
- > 3 freeze/thaw cycles of samples
- Stored or shipped at > 0°C
- Icteric, lipemic, hemolytic, substantial particulates
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Retrospective
Outcome Measure:
Establish reference in Chinese population
Outcome Time Frame:
October 2012 - March 2013
Safety Issue:
No
Authority:
China: Food and Drug Administration
Study ID:
CIM RD001
NCT ID:
NCT01738269
Start Date:
November 2012
Completion Date:
June 2013
Related Keywords:
- Ovarian Cancer
- Ovarian cancer, HE4, normal range
- Ovarian Neoplasms
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