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Study of Circulating Cancer Cells in Patients With Metastatic Breast, Ovarian, Colon, or Pancreatic Cancer


2007-11


2010-04


2010-04


80

Study Overview

Study of Circulating Cancer Cells in Patients With Metastatic Breast, Ovarian, Colon, or Pancreatic Cancer

RATIONALE: Counting the number of circulating cancer cells in samples of blood from patients with metastatic cancer may help doctors find out how much the cancer has spread. PURPOSE: This research study is looking at the number of circulating cancer cells in patients with metastatic breast cancer, ovarian cancer, colon cancer, or pancreatic cancer.

OBJECTIVES: * To assess frequency of circulating tumor cells (CTCs) in patients with metastatic ovarian, breast, pancreatic, and colon cancers. * To assess the variability in number of CTCs between patients with the same tumor type. * To correlate the number of CTCs with extent of tumor burden as measured by tumor markers, imaging, and the number of metastatic sites and proliferation and apoptotic markers. OUTLINE: Blood samples are collected before treatment and analyzed using molecular detection techniques to detect circulating cancer cells. Samples are assessed by immunofluorescence for markers of proliferation and survival (e.g., EGFR, phosphorylated EGFR, AKT, phosphorylated AKT, cytokeratins, MAPK, Src, and FAK).

  • Breast Cancer
  • Colorectal Cancer
  • Ovarian Cancer
  • Pancreatic Cancer
    • CDR0000582085
    • P30CA015083 (U.S. NIH Grant/Contract)
    • MC0744 (OTHER Identifier) (OTHER: Mayo Clinic Cancer Center)
    • 07-006779 (OTHER Identifier) (OTHER: Mayo Clinic IRB)

    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

    2009-05-09  

    N/A  

    2011-07-18  

    2009-05-09  

    N/A  

    2011-07-19  

    2009-05-12  

    N/A  

    2011-07  

    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
    : Metastatic Breast Cancer

    : Metastatic Ovarian Cancer

    : Metastatic Pancreatic Cancer

    : Metastatic Colon Cancer

    : Stage 3 Ovarian Cancer

    : Locally Advanced Pancreatic Cancer

    Primary Outcome MeasuresMeasure DescriptionTime Frame
    Frequency of circulating cancer cells (CTC)1 day
    Variability in number of CTCs between patients with the same tumor type1 day
    Correlation of the number of CTCs with extent of tumor burden as measured by tumor markers, imaging, and the number of metastatic sites and proliferation and apoptotic markers1 day
    Secondary Outcome MeasuresMeasure DescriptionTime Frame

    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:
    ALL

    Sexes Eligible for Study:

    Accepts Healthy Volunteers:

      DISEASE CHARACTERISTICS:

    • Radiographic or marker evidence of metastatic ovarian, breast, pancreatic, or colon disease
    • Hormone receptor status not specified

    • PATIENT CHARACTERISTICS:

    • Menopausal status not specified
    • No history of any prior cancer

    • PRIOR CONCURRENT THERAPY:

    • No prior therapy for metastatic disease

    Collaborators and Investigators

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

    • National Cancer Institute (NCI)

    • PRINCIPAL_INVESTIGATOR: Charles Erlichman, MD, Mayo Clinic

    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