Triple Negative Breast CancerNCT02639832
A Pilot Surveillance Study to Monitor Natural Killer Cells and Circulating Tumor Cells in Women With Previously Treated Non-metastatic Triple Negative Breast Cancer and Women With Previously Treated Non-metastatic Breast Cancer With a Confirmed BRCA Mutation.
An observational study of Triple Negative Breast Cancer and Natural Killer Cells, run by Cynvenio Biosystems at 1 site in United States.
Trial summary
The purpose of this research study is: To test blood for the presence of tumor derived circulating tumor cells (CTCs) or circulating tumor DNA (ctDNA) using an investigational medical device called the LiquidBiopsy®. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Triple Negative Breast Cancer, Natural Killer Cells, BRCA Mutation
- What is being tested?
- LiquidBiopsy®, NK VueTM
- Type of treatment
- Medical device
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Dec 2019
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Previously Treated Non-metastatic Triple Negative Breast Cancer or Breast Cancer with a confirmed BRCA mutation.
Who may be able to join
- Signed Informed Consent Form.
- Female.
- Over 18 years of age.
- Previously Treated Non-metastatic Triple Negative Breast Cancer or Women with Previously Treated Non-metastatic Breast Cancer With a confirmed BRCA Mutation who have completed therapy within three years of enrollment in this study.
- Subject may be invited to annual review of the Subject Information and Donation Schedule by email or mail follow up for five years after sampling.
- Subject provides written authorization for use and disclosure of protected health information (PHI).
Who cannot join
- Any conditions inappropriate for blood drawing.
- Known active viral or bacterial infection at time of blood draw.
- Known HIV, Hepatitis B, or Hepatitis C infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cynvenio Biosystems, Inc.
Westlake Village, California, 91361
About this study
The purpose of this research study is:
- To test blood for the presence of tumor derived circulating tumor cells (CTCs) or circulating tumor DNA (ctDNA) using an investigational medical device called the LiquidBiopsy®. Using the LiquidBiopsy® platform, recovered cells or DNA can also be investigated to obtain genetic information that may be useful to treating physicians in understanding disease.
- To test blood for natural killer cells (NK cells), which are part of the body's natural immune defense against tumors. A device called the NK VueTM Kit will be used for this test.
Read more
The LiquidBiopsy® is a new investigational device. An investigational device is one that is not approved by the United States Food and Drug Administration (FDA). The NK VueTM Kit is an investigational device in the United States but is approved in Canada and South Korea as a class II device.
If a tumor is present, very tiny numbers of tumor cells or the contents of these tumor cells can get dislodged from the tumor and swept into the bloodstream. The LiquidBiopsy® device is able to purify the tiny numbers of tumor cells or ctDNA in the blood. Even if a tumor is too small to be found by other means such as an x-ray, it is possible that ctDNA or CTCs may be found in the blood. Genetic information can then be recovered from these cells or DNA to look for genetic changes that are related to the abnormal growth in a tumor. This will potentially allow researchers to study tumor cells or tumor DNA from a blood sample instead of a biopsy sample. This may influence cancer diagnosis, treatment and drug selection in the future.
NK cells occur naturally in the body and kill tumor cells. This study will measure the activity of the NK cells in blood. A strong correlation between low NK cell activity and increased circulating tumor cells in blood has been reported.
- Being tested
- LiquidBiopsy®, NK VueTM
- Keywords
- Triple Negative Breast Cancer, Breast Cancer, Natural Killer Cells, BRCA Mutation
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiquidBiopsy®, NK VueTMDevice
The LiquidBiopsy® device will test for cells with tumor cell markers in blood. The genetic sequence of DNA recovered samples will be studied. Using NK VueTM researchers will test for NK cell activity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of cell free tumor DNA and/or circulating tumor cells from a blood sample in women with Triple Negative Breast Cancer (TNBC) or a confirmed BRCA Mutation who have completed therapy and have no evidence of active disease via LiquidBiopsy.
Measured: When NK cell activity is low for up to 3 years.
Natural Killer cell activity levels in women with Triple Negative Breast Cancer and Women with Previously Treated Non-metastatic Breast Cancer or a confirmed BRCA Mutation who have completed therapy and have no evidence of active disease via ELISA assay.
Measured: Monthly up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynvenio Biosystems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639832
- Sponsor's protocol ID
- SAIRB-15-0060
- Status last verified
- Aug 2016
- First submitted
- 10 Dec 2015
- Last updated
- 8 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Surveillance Study to Monitor Natural Killer Cells and Circulating Tumor Cells in Women With Previously Treated Non-metastatic Triple Negative Breast Cancer and Women With Previously Treated Non-metastatic Breast Cancer With a Confirmed BRCA Mutation.
- ClinicalTrials.gov ID
- NCT02639832
- Acronym / sponsor ID
- SAIRB-15-0060
- Keywords
- Triple Negative Breast Cancer, Breast Cancer, Natural Killer Cells, BRCA Mutation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Cynvenio BiosystemsIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Dec 2019 (estimated)
- First posted
- 24 Dec 2015 (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 purpose of this research study is:
- To test blood for the presence of tumor derived circulating tumor cells (CTCs) or circulating tumor DNA (ctDNA) using an investigational medical device called the LiquidBiopsy®. Using the LiquidBiopsy® platform, recovered cells or DNA can also be investigated to obtain genetic information that may be useful to treating physicians in understanding disease.
- To test blood for natural killer cells (NK cells), which are part of the body's natural immune defense against tumors. A device called the NK VueTM Kit will be used for this test.
The LiquidBiopsy® is a new investigational device. An investigational device is one that is not approved by the United States Food and Drug Administration (FDA). The NK VueTM Kit is an investigational device in the United States but is approved in Canada and South Korea as a class II device.
If a tumor is present, very tiny numbers of tumor cells or the contents of these tumor cells can get dislodged from the tumor and swept into the bloodstream. The LiquidBiopsy® device is able to purify the tiny numbers of tumor cells or ctDNA in the blood. Even if a tumor is too small to be found by other means such as an x-ray, it is possible that ctDNA or CTCs may be found in the blood. Genetic information can then be recovered from these cells or DNA to look for genetic changes that are related to the abnormal growth in a tumor. This will potentially allow researchers to study tumor cells or tumor DNA from a blood sample instead of a biopsy sample. This may influence cancer diagnosis, treatment and drug selection in the future.
NK cells occur naturally in the body and kill tumor cells. This study will measure the activity of the NK cells in blood. A strong correlation between low NK cell activity and increased circulating tumor cells in blood has been reported.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Previously Treated Non-metastatic Triple Negative Breast Cancer or Breast Cancer with a confirmed BRCA mutation.
Key inclusion criteria (6 listed)
- Signed Informed Consent Form.
- Female.
- Over 18 years of age.
- Previously Treated Non-metastatic Triple Negative Breast Cancer or Women with Previously Treated Non-metastatic Breast Cancer With a confirmed BRCA Mutation who have completed therapy within three years of enrollment in this study.
- Subject may be invited to annual review of the Subject Information and Donation Schedule by email or mail follow up for five years after sampling.
Key exclusion criteria (3 listed)
- Any conditions inappropriate for blood drawing.
- Known active viral or bacterial infection at time of blood draw.
- Known HIV, Hepatitis B, or Hepatitis C infection.
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 |
|---|---|---|
| LiquidBiopsy®, NK VueTMThe LiquidBiopsy® device will test for cells with tumor cell markers in blood. The genetic sequence of DNA recovered samples will be studied. Using NK VueTM researchers will test for NK cell activity. | Device | – |
Primary outcome
Presence of cell free tumor DNA and/or circulating tumor cells from a blood sample in women with Triple Negative Breast Cancer (TNBC) or a confirmed BRCA Mutation who have completed therapy and have no evidence of active disease via LiquidBiopsy.
Time frame: When NK cell activity is low for up to 3 years.
Natural Killer cell activity levels in women with Triple Negative Breast Cancer and Women with Previously Treated Non-metastatic Breast Cancer or a confirmed BRCA Mutation who have completed therapy and have no evidence of active disease via ELISA assay.
Time frame: Monthly up to 3 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
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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.
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 Triple Negative Breast Cancer and Natural Killer Cells, run by Cynvenio Biosystems at 1 site in United States.
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 6 inclusion and 3 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 8 Aug 2016. 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 United States. 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?
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?
Presence of cell free tumor DNA and/or circulating tumor cells from a blood sample in women with Triple Negative Breast Cancer (TNBC) or a confirmed BRCA Mutation who have completed therapy and have no evidence of active disease via LiquidBiopsy. (time frame: When NK cell activity is low for up to 3 years.). 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 8 Aug 2016.