Elecsys HE4 Chinese Reference Value Study

A Multi-center Reference Value Study of Elecsys HE4 in Chinese Population

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01738269

Enrollment

2351

Registered

2012-11-30

Start date

2012-11-30

Completion date

2013-05-31

Last updated

2013-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

Ovarian cancer, HE4, normal range

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Establish reference in Chinese population	October 2012 - March 2013

Countries

China

Outcome results