Elecsys HE4 Chinese Reference Value Study
This study is currently recruiting participants.
Verified December 2012 by Chinese PLA General Hospital
Sponsor:
Chinese PLA General Hospital
Information provided by (Responsible Party):
Yaping Tian, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01738269
First received: November 28, 2012
Last updated: December 3, 2012
Last verified: December 2012
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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
| Estimated Enrollment: | 1750 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | March 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.
- Apparently Healthy: 300
- Non-malignant Conditions: 650
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01738269
Locations
| China | |
| China PLA General Hospital | Recruiting |
| Beijing, China | |
| Contact: Xinyu Wen +86 13911695942 wendy36500@yahoo.com.cn | |
| Contact: Yaping Tian +86 13701150396 tianyp61@gmail.com | |
| Principal Investigator: Yaping Tian, Professor | |
| The First Affiliated Hospital of Fujian Medical University | Recruiting |
| Fuzhou, China | |
| Contact: Jing Chen chenear9040@sina.com | |
| Principal Investigator: Qishui Ou, Professor | |
| Sun Yat-Sen University Cancer Center | Recruiting |
| Guangzhou, China | |
| Contact: Wen Liu liuwen@sysucc.org.cn | |
| Principal Investigator: Wanli Liu, Professor | |
| Shandong University Qilu Hospital | Recruiting |
| Jinan, China | |
| Contact: Guixi Zheng qiluzgx@163.com | |
| Principal Investigator: Chuanxin Wang, Professor | |
| Fudan University Shanghai Cancer Center | Recruiting |
| Shanghai, China | |
| Contact: YIn Chen 1251487447@qq.com | |
| Principal Investigator: Lin Guo, Professor | |
| Tianjin Cancer Hospital | Recruiting |
| Tianjin, China | |
| Contact: Aimin Zhang +86 18622221301 | |
| Principal Investigator: Meng Zhang, Professor | |
| Xinjiang Medical University Cancer Center | Recruiting |
| Urumchi, China | |
| Contact: Yishan Huo 158719972@qq.com | |
| Principal Investigator: Yanchun Huang, Professor | |
| Tongji Hospital Tongji Medical Colege of HUST | Recruiting |
| Wuhan, China | |
| Contact: Huijun Li 18986030216@163.com | |
| Principal Investigator: Ziyong Sun, Professor | |
| Zhongshan Hospital Xiamen University | Recruiting |
| Xiamen, China | |
| Contact: Huiming Ye 18950173406@163.com | |
| Principal Investigator: Zhongying Zhang, Professor | |
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: | December 3, 2012 |
| 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 May 16, 2013