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Clinical Trials/NCT02904135
NCT02904135
Completed
Not Applicable

Collection of Circulating Tumor Cells From the Peripheral Blood of Metastatic Breast Cancer Patients

MiCareo Taiwan Co., Ltd.1 site in 1 country141 target enrollmentFebruary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Circulating Tumor Cells (CTCs)
Sponsor
MiCareo Taiwan Co., Ltd.
Enrollment
141
Locations
1
Primary Endpoint
Overall survival(OS)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

To address the challenges of isolating and analyzing rare cells, this study aims to validate the instrumentation, the test protocols, and the analysis of patient's outcome to show the instrument's capability to reproducibly and accurately detect CTCs in cancer patients. In order to facilitate the validation process, investigators will only focus on metastatic patients for whom CTCs supposedly present at higher abundance. Investigators propose to enroll cohorts of metastatic breast cancer patients. Blood samples will be collected from these patients before they start any new line of therapy as determined by their doctors. The specific aims are to isolate, enumerate and analyze the number and/or molecular information of circulating tumor cells in patient blood using microfluidic chip-based sorting, imaging, and molecular profiling techniques. Investigators will use this study to optimize diagnostic instrumentation, test blood processing protocols and CTC analysis algorithm. During this study investigators will collect patients' clinical information related to cancer, as well as the patients' survival status to validate the system's prognosis ability.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
December 2016
Last Updated
9 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
  • Progressive and measurable metastatic breast cancer.
  • Commencement of new anti-cancer chemotherapy or palliative care.
  • ECOG performance status equal or less than grade 2.

Exclusion Criteria

  • Subject has received any investigational agent, not explicitly approved by MiCareo, within last one year.
  • Subject being identified with any blood borne infectious disease.
  • Subject has received anticancer chemotherapy within last one month. (not including hormone therapy, or target therapy)

Outcomes

Primary Outcomes

Overall survival(OS)

Time Frame: 3 years

Study Sites (1)

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