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.
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/23/2016 |
| Start Date: | December 2015 |
| Contact: | Sayer |
| Email: | clientservices@cynvenio.com |
| Phone: | 805-777-0017 |
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.
- 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.
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
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