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OpenTrials
Completed

NCT Number: NCT02904135

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

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.

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Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Keelung Chang Gung Memorial Hospital

Keelung, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • Pregnancy.

Treatment and study plan

Primary outcomes

  1. Overall survival(OS)

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

MiCareo Taiwan Co., Ltd.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 16, 2016
Registry last updated
Mar 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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