Circulating Tumor Cells.BreastPhase 3NCT03006055
The Detection of Circulating Tumor Cells (CTCs) in Breast Cancer With a Novel in Vivo Device
A Phase 3 study testing Circulating tumor cells in people with Circulating Tumor Cells.Breast, run by Beijing Viroad Biotechnology Co., Ltd. at 1 site in China.
Trial summary
The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide which is CE approved. Application data of CellCollector in China is not available now. The purpose of this clinical trial is to confirm the validation and safety of CellCollector in Chinese patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Circulating Tumor Cells.Breast
- What is being tested?
- Circulating tumor cells
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Dec 2016
- Phase
- Phase 3
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastasis breast cancer confirmed with imaging examination
- Have agreed to undergo CTC analysis in vivo;
- ECOG：0-2
Who cannot join
- Non-metastasis breast cancer
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The 307th Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, 100071
ZF Jiang
About this study
The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide which is CE approved. Application data of CellCollector in China is not available now. The purpose of this clinical trial is to confirm the validation and safety of CellCollector in Chinese patients.
- Conditions
- Circulating Tumor Cells.Breast
- Being tested
- Circulating tumor cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating tumor cellsDevice
| Study group | Role | What they receive |
|---|---|---|
| MBC Group | Experimental | metastatic breast cancer Age：18-75 ECOG:0-2 Receives: Device: Circulating tumor cells |
| Control Group | Experimental | benign breast tumour Age：18-75 ECOG:0-2 Receives: Device: Circulating tumor cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of CellCollector
CTC enumeration and detection rate in Chinese patients with metastasis breast cancer will be analyzed by using CellCollector.
Measured: 6 month
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of participants with treatment-related adverse events and blood IgE level will be analyzed after CellCollector application.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulating Tumor Cells.BreastStudies 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 3
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Viroad Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006055
- Sponsor's protocol ID
- VIROAD01
- Status last verified
- Dec 2016
- First submitted
- 21 Dec 2016
- Last updated
- 2 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Detection of Circulating Tumor Cells (CTCs) in Breast Cancer With a Novel in Vivo Device
- ClinicalTrials.gov ID
- NCT03006055
- Acronym / sponsor ID
- VIROAD01
- Conditions
- Circulating Tumor Cells.Breast
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Beijing Viroad Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 30 Dec 2016 (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.
The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide which is CE approved. Application data of CellCollector in China is not available now. The purpose of this clinical trial is to confirm the validation and safety of CellCollector in Chinese patients.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBC Group | Experimental | Device: Circulating tumor cellsmetastatic breast cancer Age：18-75 ECOG:0-2 |
| Control Group | Experimental | Device: Circulating tumor cellsbenign breast tumour Age：18-75 ECOG:0-2 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Metastasis breast cancer confirmed with imaging examination
- Have agreed to undergo CTC analysis in vivo;
- ECOG：0-2
Key exclusion criteria (1 listed)
- Non-metastasis breast cancer
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 |
|---|---|---|
| Circulating tumor cells | Device | Control Group, MBC Group |
Primary outcome
Validation of CellCollector
Time frame: 6 month
CTC enumeration and detection rate in Chinese patients with metastasis breast cancer will be analyzed by using CellCollector.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 6 month
Number of participants with treatment-related adverse events and blood IgE level will be analyzed after CellCollector application.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Circulating tumor cells in people with Circulating Tumor Cells.Breast, run by Beijing Viroad Biotechnology 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 3 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 2 Jan 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 YH Dong, MD (+86031189928691, dongyh_viroad@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of CellCollector (time frame: 6 month). The study lists 2 primary outcomes in all. 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 2 Jan 2017.