Elecsys HE4 Chinese Reference Value Study

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01738269
• Other study ID #: CIM RD001
• Status: Completed
• Phase: N/A
• First received: November 28, 2012
• Last updated: July 30, 2013
• Start date: November 2012
• Est. completion date: May 2013

Study information

• Verified date: July 2013
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2351
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
China	China PLA General Hospital	Beijing
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou
China	Sun Yat-Sen University Cancer Center	Guangzhou
China	Shandong University Qilu Hospital	Jinan
China	Fudan University Shanghai Cancer Center	Shanghai
China	Tianjin Cancer Hospital	Tianjin
China	Xinjiang Medical University Cancer Center	Urumchi
China	Tongji Hospital Tongji Medical Colege of HUST	Wuhan
China	Zhongshan Hospital Xiamen University	Xiamen

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish reference in Chinese population		October 2012 - March 2013	No