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A Study to Isolate and Test Circulating Tumor Cells Using the ClearCell® FX EP+ System

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT02370303
Collaborator
Clearbridge Biomedics (Industry)
23
Enrollment
1
Location
23.3
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to isolate and measure circulating tumor cells in the blood stream to advance detection of cancer and treatment monitoring. In this study, the investigators will utilize the novel technology for circulating tumor cell detection in order to evaluate their presence in patients with lung cancer.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The plan is to collect both blood and tumor samples from the patient's lung cancer in order to validate this technology in detecting circulating tumor cells. The investigators will also obtain a postoperative blood sample to see if there is a decrease in the overall circulating tumor cell measurement once the tumor has been surgically removed.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    23 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    A Pilot Study to Isolate and Test Circulating Tumor Cells Using the ClearCell® FX EP+ System
    Study Start Date :
    Aug 1, 2014
    Actual Primary Completion Date :
    Jul 9, 2016
    Actual Study Completion Date :
    Jul 9, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Number and types of mutations in the primary tumor. [Within 1 year]

    2. Number and type of mutations detectable in the matched circulating tumor cell samples. [Within 1 year]

    Secondary Outcome Measures

    1. Concordance of mutations detected by either method. [Within 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Stage IB and above non-small cell lung cancer or metastatic lung cancer

    • Age >18 years old

    • Willing and able to consent to study

    • No prior history of neoadjuvant therapy.

    Exclusion Criteria:

    • Age <18 years old

    • Unable to provide consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic
    • Clearbridge Biomedics

    Investigators

    • Principal Investigator: Dennis Wigle, MD, PhD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dennis Wigle, PI, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT02370303
    Other Study ID Numbers:
    • 14-003962
    First Posted:
    Feb 24, 2015
    Last Update Posted:
    Mar 21, 2018
    Last Verified:
    Mar 1, 2018
    Additional relevant MeSH terms:
    Carcinoma
    Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Neoplastic Cells, Circulating
    Lung Neoplasms

    Study Results

    No Results Posted as of Mar 21, 2018