Elecsys HE4 Chinese Reference Value Study
A Multi-center Reference Value Study of Elecsys HE4 in Chinese Population
1 other identifier
observational
2,351
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2012
Shorter than P25 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 28, 2012
CompletedFirst Posted
Study publicly available on registry
November 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedJuly 31, 2013
July 1, 2013
6 months
November 28, 2012
July 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Establish reference in Chinese population
October 2012 - March 2013
Study Arms (3)
Apparently healthy subjects
Non-malignant conditions subjects
Malignant conditions subjects
Eligibility Criteria
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
You may qualify if:
- appropriate clinical data
- normal appearance of sample
- minimum 0.5 ml volume available
You may not qualify if:
- \< 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
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
Ürümqi, China
Tongji Hospital Tongji Medical Colege of HUST
Wuhan, China
Zhongshan Hospital Xiamen University
Xiamen, China
Biospecimen
Serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Biochemistry Department
Study Record Dates
First Submitted
November 28, 2012
First Posted
November 30, 2012
Study Start
November 1, 2012
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
July 31, 2013
Record last verified: 2013-07