Elecsys HE4 Chinese Reference Value Study

NCT ID: NCT01738269

Last Updated: 2013-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2351 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-05-31

Brief Summary

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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

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Conditions

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Ovarian Cancer

Keywords

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Ovarian cancer, HE4, normal range

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Apparently healthy subjects

No interventions assigned to this group

Non-malignant conditions subjects

No interventions assigned to this group

Malignant conditions subjects

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* appropriate clinical data
* normal appearance of sample
* minimum 0.5 ml volume available

Exclusion Criteria

* \< 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yaping Tian

Director of Biochemistry Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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China PLA General Hospital

Beijing, , China

Site Status

The First Affiliated Hospital of Fujian Medical University

Fuzhou, , China

Site Status

Sun Yat-Sen University Cancer Center

Guangzhou, , China

Site Status

Shandong University Qilu Hospital

Jinan, , China

Site Status

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status

Tianjin Cancer Hospital

Tianjin, , China

Site Status

Xinjiang Medical University Cancer Center

Ürümqi, , China

Site Status

Tongji Hospital Tongji Medical Colege of HUST

Wuhan, , China

Site Status

Zhongshan Hospital Xiamen University

Xiamen, , China

Site Status

Countries

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China

Other Identifiers

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CIM RD001

Identifier Type: -

Identifier Source: org_study_id