Elecsys HE4 Chinese Reference Value Study

Completed

• Conditions: Ovarian Cancer

• Registration Number: NCT01738269
• Lead Sponsor: Chinese PLA General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-28
• Study First Submitted QC: 2012-11-28
• Study First Posted: 2012-11-30
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-30
• Last Update Posted: 2013-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2351

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establish reference in Chinese population	October 2012 - March 2013

Trial Locations

Locations (9)

Shandong University Qilu Hospital; 🇨🇳 Jinan, China

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China

Zhongshan Hospital Xiamen University; 🇨🇳 Xiamen, China

China PLA General Hospital; 🇨🇳 Beijing, China

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, China

Tianjin Cancer Hospital; 🇨🇳 Tianjin, China

Xinjiang Medical University Cancer Center; 🇨🇳 Urumchi, China

Sun Yat-Sen University Cancer Center; 🇨🇳 Guangzhou, China

Tongji Hospital Tongji Medical Colege of HUST; 🇨🇳 Wuhan, China