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Elecsys HE4 Chinese Reference Value Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01738269
Recruitment Status : Completed
First Posted : November 30, 2012
Last Update Posted : July 31, 2013
Information provided by (Responsible Party):
Yaping Tian, 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.

Condition or disease
Ovarian Cancer

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Study Type : Observational
Actual Enrollment : 2351 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Multi-center Reference Value Study of Elecsys HE4 in Chinese Population
Study Start Date : November 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Apparently healthy subjects
Non-malignant conditions subjects
Malignant conditions subjects

Primary Outcome Measures :
  1. Establish reference in Chinese population [ Time Frame: October 2012 - March 2013 ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Except for samples from apparently healthy subjects, specimens for the entire clinical section are supposed to be available in banks / archives. Thus, for the most part, no prospective collection of serum should be necessary. Pseudonymized residual samples will be used. All elements of the clinical part require samples from well characterized cohorts are showed below.

  1. Apparently Healthy: 300
  2. Non-malignant Conditions: 650
  3. Malignant Conditions: 800

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01738269

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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, China
Sponsors and Collaborators
Chinese PLA General Hospital

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Responsible Party: Yaping Tian, Director of Biochemistry Department, Chinese PLA General Hospital Identifier: NCT01738269    
Other Study ID Numbers: CIM RD001
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: July 31, 2013
Last Verified: July 2013
Keywords provided by Yaping Tian, Chinese PLA General Hospital:
Ovarian cancer, HE4, normal range
Additional relevant MeSH terms:
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Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders