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.

August 4, 2016 updated by: Cynvenio Biosystems

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Westlake Village, California, United States, 91361
        • Cynvenio Biosystems, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Previously Treated Non-metastatic Triple Negative Breast Cancer or Breast Cancer with a confirmed BRCA mutation.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.
Monthly up to 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cynvenio Biosystems

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

December 10, 2015

First Submitted That Met QC Criteria

December 21, 2015

First Posted (Estimate)

December 24, 2015

Study Record Updates

Last Update Posted (Estimate)

August 8, 2016

Last Update Submitted That Met QC Criteria

August 4, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAIRB-15-0060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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