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Clinical Trial Record

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China CellSearch Study

2010-03-25

2011-06-22

2014-01-06

500

Study Overview

China CellSearch Study

The study is designed to confirm the current indication (below) of the CellSearch® Circulating Tumor Cell Kit in metastatic breast cancer (MBC) patients for use of the kit in China. The CellSearch® Circulating Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood. The presence of CTC in the peripheral blood, as detected by the CellSearch® Circulating Tumor Cell Kit, is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast cancer. This test is to be used as an aid in the monitoring of patients with metastatic breast cancer. Serial testing for CTC should be used in conjunction with other clinical methods for monitoring metastatic breast cancer. Evaluation of CTC at any time during the course of disease allows assessment of patient prognosis and is predictive of progression free survival and overall survival.

A longitudinal, multi-center, prospective study will be conducted in MBC patients to evaluate the ability of CTC to predict the patients' prognosis. A separate population of healthy and benign disease subjects will serve as controls to compare the CTC incidence in this control group versus the MBC group at baseline. Correlation between CTC and radiographic response to the systemic therapies in the MBC study group will also be assessed. 300 MBC patients, each of whom will provide a series of at least 3 blood draws (baseline, 3-4 weeks and 6-8 weeks after the initiation of the systemic therapy) for CTC analysis, will be enrolled. All MBC patients will be followed for a maximum of 36 months for disease progression and survival. 200 healthy and benign disease volunteers, each of whom will donate blood 1 time for CTC analysis, will be enrolled as controls.

  • Metastatic Breast Cancer
  • Benign Breast Disease
    • 200901

    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 Registration Dates Results Reporting Dates Study Record Updates

    2010-05-04  

    N/A  

    2019-11-13  

    2010-05-04  

    N/A  

    2019-11-15  

    2010-05-05  

    N/A  

    2019-11  

    Study Plan

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

    Design Details

    Primary Purpose:
    N/A

    Allocation:
    N/A

    Interventional Model:
    N/A

    Masking:
    N/A

    Arms and Interventions

    Participant Group/ArmIntervention/Treatment
    : MBC patients

    300 MBC patients, each of whom will provide a series of at least 3 blood draws (baseline, 3-4 weeks and 6-8 weeks after the initiation of the systemic therapy) for CTC analysis, will be enrolled. All MBC patients will be followed for a maximum of 36 month

    : Benign disease volunteers

    100 Benign disease volunteers whom will donate blood 1 time for CTC analysis, will be enrolled as controls.

    : Healthy volunteers

    100 Healthy volunteers whom will donate blood 1 time for CTC analysis, will be enrolled as controls.

    Primary Outcome MeasuresMeasure DescriptionTime Frame
    Ability of CTC levels to predict progression-free survival (PFS) in MBC patients.12 months
    Secondary Outcome MeasuresMeasure DescriptionTime Frame
    Ability of CTC levels to predict overall survival (OS) in MBC patients.3 years
    Agreement between CTC counts (3-4 weeks and 6-8 weeks) after the initiation of a new line of systemic therapy and the patient's response as determined by imaging evaluation (6-8 weeks after the initiation of therapy) in MBC patients.12 months

    Contacts and Locations

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

    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.

    Ages Eligible for Study:
    FEMALE

    Sexes Eligible for Study:
    18 Years

    Accepts Healthy Volunteers:
    1

      Inclusion Criteria

    • Female
    • over 18 and less than 70 years of age
    • Subject having agreed to participate in the study and follow the study procedures by providing written informed consent prior entering the study.
    • For MBC Subject Set only Confirmed metastatic breast cancer patient with at least one measurable solid tumor according to the RECIST guideline Starting a new line of systemic therapy which is recommended in the Chinese edition of NCCN Clinical Practice Guidelines in Oncology Breast Cancer Guideline 2009 line of chemotherapy should be over 3 ECOG performance grade of 0 to 2 Life expectancy over 3 months
    • For Healthy Subject Set only Medical examinations detect no breast benign and malignant tumors
    • For Benign Breast Disease Subject Set only Pathology diagnosed breast benign tumor disease

      • Exclusion Criteria

    • Self reported pregnancy
    • For MBC Subject Set only Prior history of other malignancy Patients who have surgery to remove any metastatic lesions or receive radiation therapy during her participation in the study
    • For Healthy Subject Set only Prior history of breast benign tumor disease or any malignancy Any conditions inappropriate for blood drawing
    • For Benign Breast Disease Subject Set only Prior history of any malignancy Any conditions inappropriate for blood drawing

    Collaborators and Investigators

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

      • STUDY_CHAIR: Zefei Jiang, Doctor, 307 Hosptial of PLA

      Publications

      The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

      General Publications

      No publications available

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