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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.

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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

Tracking Information
First Submitted Date December 10, 2015
First Posted Date December 24, 2015
Last Update Posted Date August 8, 2016
Study Start Date December 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 8, 2016)
  • 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. ]
Original Primary Outcome Measures
 (submitted: December 21, 2015)
  • Presence of cell free tumor DNA and/or circulating tumor cells from a blood sample in women with Triple Negative Breast Cancer (TNBC) 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 who have completed therapy and have no evidence of active disease via ELISA assay. [ Time Frame: Monthly up to 3 years. ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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.
Official Title Not Provided
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Previously Treated Non-metastatic Triple Negative Breast Cancer or Breast Cancer with a confirmed BRCA mutation.
Condition
  • Triple Negative Breast Cancer
  • Natural Killer Cells
  • BRCA Mutation
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: August 4, 2016)
210
Original Estimated Enrollment
 (submitted: December 21, 2015)
250
Study Completion Date Not Provided
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02639832
Other Study ID Numbers SAIRB-15-0060
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cynvenio Biosystems
Study Sponsor Cynvenio Biosystems
Collaborators Not Provided
Investigators Not Provided
PRS Account Cynvenio Biosystems
Verification Date August 2016