Elecsys HE4 Chinese Reference Value Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yaping Tian, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01738269
First received: November 28, 2012
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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
Ovarian Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Multi-center Reference Value Study of Elecsys HE4 in Chinese Population

Resource links provided by NLM:


Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • Establish reference in Chinese population [ Time Frame: October 2012 - March 2013 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum


Enrollment: 2351
Study Start Date: November 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Apparently healthy subjects
Non-malignant conditions subjects
Malignant conditions subjects

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738269

Locations
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, China
Sponsors and Collaborators
Chinese PLA General Hospital
  More Information

No publications provided

Responsible Party: Yaping Tian, Director of Biochemistry Department, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01738269     History of Changes
Other Study ID Numbers: CIM RD001
Study First Received: November 28, 2012
Last Updated: July 30, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese PLA General Hospital:
Ovarian cancer, HE4, normal range

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on August 28, 2014