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

March 21, 2017 updated by: MiCareo Taiwan Co., Ltd.
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

141

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

  • Taiwan
      • Keelung City, Taiwan
        • Keelung Chang Gung Memorial Hospital

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

metastatic breast cancer (mBC) patients

Description

Inclusion Criteria:

  1. 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.
  2. Progressive and measurable metastatic breast cancer.
  3. Commencement of new anti-cancer chemotherapy or palliative care.
  4. ECOG performance status equal or less than grade 2.

Exclusion Criteria:

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

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

Cohorts and Interventions

Group / Cohort
first stage
During the first stage, the patient's baseline blood sample will be mainly used for validating and troubleshooting our instrument with clinical samples.
second stage
During the second stage, 40 patients will be followed for up to three years after their baseline blood draw to obtain data on their survival status. The CTC results and follow-up data obtained from these samples will help to analyze any correlation with the patient's clinical outcome and further validate the prognosis ability of MiCareo's CTC platform for mBC patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival(OS)
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

MiCareo Taiwan Co., Ltd.

Investigators

  • Study Director: Chen Jui-Lin, CEO

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

February 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 13, 2016

First Submitted That Met QC Criteria

September 15, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Actual)

March 23, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBC 2.7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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