Breast CancerNCT02324101
Clinical Trial of Quantitative Detection Kit for Hsp90α in Breast Cancer
A study testing Hsp90 in people with Breast Cancer, run by Beijing Protgen Biotechnology Development Co., Ltd. at 1 site in China.
Trial summary
Detect plasma Hsp90α concentration of breast cancer patients, healthy volunteers, benign breast diseases patients Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Hsp90
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Dec 2014
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- breast cancer patients, healthy volunteers, benign breast diseases patients
Who cannot join
- Patients who previously received radiotherapy
Trial locations and contacts
1 site in 1 country.
Zhongsheng Tong, MD contact
China1 site, 1 recruiting
- Recruiting
Tianjin cancer hospital
Tianjin, Tianjin Municipality
Zhongsheng Tong, MD, 022 ext. 23340123
About this study
Detect plasma Hsp90α concentration of breast cancer patients, healthy volunteers, benign breast diseases patients
Read the detailed description
Detect plasma Hsp90α concentration of breast cancer patients, healthy volunteers, benign breast diseases patients, validate accuracy, specificity and sensitivity of Hsp90α kit.
- Conditions
- Breast Cancer
- Being tested
- Hsp90
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hsp90Device
Also called Biomarker
Detect plasma Hsp90α concentration
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer | Experimental | Detect plasma Hsp90α concentration of breast cancer patients Receives: Device: Hsp90 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hsp90α Concentration(ng/ml) of plasma
Detect Hsp90α Concentration(ng/ml) of plasma and calculate the accuracy, specificity and sensitivity of Hsp90α kit
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startApr 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Protgen Biotechnology Development Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhongsheng Tong, MD, Principal investigator, Tianjin cance hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324101
- Sponsor's protocol ID
- hsp90a2011-02
- Status last verified
- Apr 2013
- First submitted
- 14 Dec 2014
- Last updated
- 24 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Quantitative Detection Kit for Hsp90α in Breast Cancer
- ClinicalTrials.gov ID
- NCT02324101
- Acronym / sponsor ID
- hsp90a2011-02
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Beijing Protgen Biotechnology Development Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 24 Dec 2014 (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.
Detect plasma Hsp90α concentration of breast cancer patients, healthy volunteers, benign breast diseases patients
Detailed description
Detect plasma Hsp90α concentration of breast cancer patients, healthy volunteers, benign breast diseases patients, validate accuracy, specificity and sensitivity of Hsp90α kit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer | Experimental | Device: Hsp90Detect plasma Hsp90α concentration of breast cancer patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- breast cancer patients, healthy volunteers, benign breast diseases patients
Key exclusion criteria (1 listed)
- Patients who previously received radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hsp90Also: BiomarkerDetect plasma Hsp90α concentration | Device | Breast cancer |
Primary outcome
Hsp90α Concentration(ng/ml) of plasma
Time frame: 4 months
Detect Hsp90α Concentration(ng/ml) of plasma and calculate the accuracy, specificity and sensitivity of Hsp90α kit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2014.
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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.
Zhongsheng Tong, MD contact
Zhongsheng Tong, MD principal investigator
Tianjin cance hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hsp90 in people with Breast Cancer, run by Beijing Protgen Biotechnology Development Co., Ltd. at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhongsheng Tong, MD (022 ext. 23340123), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hsp90α Concentration(ng/ml) of plasma (time frame: 4 months). 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 24 Dec 2014.