Ovarian CancerNCT01738269
Elecsys HE4 Chinese Reference Value Study
An observational study of Ovarian Cancer, run by Chinese PLA General Hospital at 9 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer
- How many people
- 2,351 participants
- Where
- 9 sitesChina
- Study dates
- Nov 2012to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- appropriate clinical data
- normal appearance of sample
- minimum 0.5 ml volume available
Who cannot join
- < 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
China PLA General Hospital
Beijing
The First Affiliated Hospital of Fujian Medical University
Fuzhou
Sun Yat-Sen University Cancer Center
Guangzhou
Shandong University Qilu Hospital
Jinan
Fudan University Shanghai Cancer Center
Shanghai
Tianjin Cancer Hospital
Tianjin
Xinjiang Medical University Cancer Center
Ürümqi
Tongji Hospital Tongji Medical Colege of HUST
Wuhan
Zhongshan Hospital Xiamen University
Xiamen
About this study
Official title: A Multi-center Reference Value Study of Elecsys HE4 in Chinese Population
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.
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian cancer, HE4, normal range
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Apparently healthy subjects | Not described | |
| Non-malignant conditions subjects | Not described | |
| Malignant conditions subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish reference in Chinese population
Measured: October 2012 - March 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaping Tian, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738269
- Sponsor's protocol ID
- CIM RD001
- Status last verified
- Jul 2013
- First submitted
- 28 Nov 2012
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Reference Value Study of Elecsys HE4 in Chinese Population
- ClinicalTrials.gov ID
- NCT01738269
- Acronym / sponsor ID
- CIM RD001
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian cancer, HE4, normal range
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,351 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Apparently healthy subjects | – | – |
| Non-malignant conditions subjects | – | – |
| Malignant conditions subjects | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- appropriate clinical data
- normal appearance of sample
- minimum 0.5 ml volume available
Key exclusion criteria (6 listed)
- < 18 years of age
- insufficient volume
- insufficient clinical information
- > 3 freeze/thaw cycles of samples
- Stored or shipped at > 0°C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establish reference in Chinese population
Time frame: October 2012 - March 2013
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Chinese PLA General Hospital at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish reference in Chinese population (time frame: October 2012 - March 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2013.