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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02639832
Recruitment Status : Unknown
Verified August 2016 by Cynvenio Biosystems.
Recruitment status was:  Active, not recruiting
First Posted : December 24, 2015
Last Update Posted : August 8, 2016
Sponsor:
Information provided by (Responsible Party):
Cynvenio Biosystems

Brief 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®. 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.


Condition or disease Intervention/treatment
Triple Negative Breast Cancer Natural Killer Cells BRCA Mutation Device: LiquidBiopsy®, NK VueTM

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Study Type : Observational
Actual Enrollment : 210 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : December 2015
Estimated Primary Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer


Intervention Details:
  • Device: LiquidBiopsy®, NK VueTM
    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.


Primary Outcome Measures :
  1. 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. ]
  2. 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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Previously Treated Non-metastatic Triple Negative Breast Cancer or Breast Cancer with a confirmed BRCA mutation.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639832


Locations
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United States, California
Cynvenio Biosystems, Inc.
Westlake Village, California, United States, 91361
Sponsors and Collaborators
Cynvenio Biosystems
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Responsible Party: Cynvenio Biosystems
ClinicalTrials.gov Identifier: NCT02639832    
Other Study ID Numbers: SAIRB-15-0060
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: August 2016
Keywords provided by Cynvenio Biosystems:
Triple Negative Breast Cancer
Breast Cancer
Natural Killer Cells
BRCA Mutation
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases