Circulating Tumor Cells (CTCs)NCT02904135
Collection of Circulating Tumor Cells From the Peripheral Blood of Metastatic Breast Cancer Patients
An observational study of Circulating Tumor Cells (CTCs), run by MiCareo Taiwan Co., Ltd. at 1 site in Taiwan.
Trial summary
To address the challenges of isolating and analyzing rare cells, this study aims to validate the instrumentation, the test protocols, and the analysis of patient's outcome to show the instrument's capability to reproducibly and accurately detect CTCs in cancer patients. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Circulating Tumor Cells (CTCs)
- How many people
- 141 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2014to Dec 2016
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: metastatic breast cancer (mBC) patients
Who may be able to join
- Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
- Progressive and measurable metastatic breast cancer.
- Commencement of new anti-cancer chemotherapy or palliative care.
- ECOG performance status equal or less than grade 2.
Who cannot join
- Subject has received any investigational agent, not explicitly approved by MiCareo, within last one year.
- Subject being identified with any blood borne infectious disease.
- Subject has received anticancer chemotherapy within last one month. (not including hormone therapy, or target therapy)
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
To address the challenges of isolating and analyzing rare cells, this study aims to validate the instrumentation, the test protocols, and the analysis of patient's outcome to show the instrument's capability to reproducibly and accurately detect CTCs in cancer patients. In order to facilitate the validation process, investigators will only focus on metastatic patients for whom CTCs supposedly present at higher abundance. Investigators propose to enroll cohorts of metastatic breast cancer patients. Blood samples will be collected from these patients before they start any new line of therapy as determined by their doctors. The specific aims are to isolate, enumerate and analyze the number and/or molecular information of circulating tumor cells in patient blood using microfluidic chip-based sorting, imaging, and molecular profiling techniques. Investigators will use this study to optimize diagnostic instrumentation, test blood processing protocols and CTC analysis algorithm. During this study investigators will collect patients' clinical information related to cancer, as well as the patients' survival status to validate the system's prognosis ability.
- Conditions
- Circulating Tumor Cells (CTCs)
- Keywords
- Circulating Tumor Cells
- Medical subject headings
- Neoplastic Cells, Circulating
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 |
|---|---|---|
| first stage | During the first stage, the patient's baseline blood sample will be mainly used for validating and troubleshooting our instrument with clinical samples. | |
| second stage | During the second stage, 40 patients will be followed for up to three years after their baseline blood draw to obtain data on their survival status. The CTC results and follow-up data obtained from these samples will help to analyze any correlation with the patient's clinical outcome and further validate the prognosis ability of MiCareo's CTC platform for mBC patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival(OS)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startFeb 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulating Tumor Cells (CTCs)Studies 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
- Prospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiCareo Taiwan Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chen Jui-Lin, Study director, CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904135
- Sponsor's protocol ID
- MBC 2.7
- Status last verified
- Mar 2017
- First submitted
- 13 Sep 2016
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Circulating Tumor Cells From the Peripheral Blood of Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02904135
- Acronym / sponsor ID
- MBC 2.7
- Conditions
- Circulating Tumor Cells (CTCs)
- Keywords
- Circulating Tumor Cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- MiCareo Taiwan Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Sep 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.
To address the challenges of isolating and analyzing rare cells, this study aims to validate the instrumentation, the test protocols, and the analysis of patient's outcome to show the instrument's capability to reproducibly and accurately detect CTCs in cancer patients. In order to facilitate the validation process, investigators will only focus on metastatic patients for whom CTCs supposedly present at higher abundance. Investigators propose to enroll cohorts of metastatic breast cancer patients. Blood samples will be collected from these patients before they start any new line of therapy as determined by their doctors. The specific aims are to isolate, enumerate and analyze the number and/or molecular information of circulating tumor cells in patient blood using microfluidic chip-based sorting, imaging, and molecular profiling techniques. Investigators will use this study to optimize diagnostic instrumentation, test blood processing protocols and CTC analysis algorithm. During this study investigators will collect patients' clinical information related to cancer, as well as the patients' survival status to validate the system's prognosis ability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first stage | – | –During the first stage, the patient's baseline blood sample will be mainly used for validating and troubleshooting our instrument with clinical samples. |
| second stage | – | –During the second stage, 40 patients will be followed for up to three years after their baseline blood draw to obtain data on their survival status. The CTC results and follow-up data obtained from these samples will help to analyze any correlation with the patient's clinical outcome and further validate the prognosis ability of MiCareo's CTC platform for mBC patients. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- metastatic breast cancer (mBC) patients
Key inclusion criteria (4 listed)
- Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
- Progressive and measurable metastatic breast cancer.
- Commencement of new anti-cancer chemotherapy or palliative care.
- ECOG performance status equal or less than grade 2.
Key exclusion criteria (4 listed)
- Subject has received any investigational agent, not explicitly approved by MiCareo, within last one year.
- Subject being identified with any blood borne infectious disease.
- Subject has received anticancer chemotherapy within last one month. (not including hormone therapy, or target therapy)
- Pregnancy.
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
Overall survival(OS)
Time frame: 3 years
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 23 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
Chen Jui-Lin study director
CEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circulating Tumor Cells (CTCs), run by MiCareo Taiwan Co., Ltd. at 1 site in Taiwan.
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 4 inclusion and 4 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 23 Mar 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 Taiwan. 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?
Overall survival(OS) (time frame: 3 years). 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 23 Mar 2017.