Elecsys HE4 Chinese Reference Value Study

Chinese PLA General Hospital (301 Hospital)

Status: Completed

Conditions: Ovarian Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01738269

CIM RD001

Details and patient eligibility

About

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.

Enrollment: 2,351 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

2,351 participants in 3 patient groups

Apparently healthy subjects

Non-malignant conditions subjects

Malignant conditions subjects