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Utilization of the OncoCEE™ Platform to Evaluate Selected Biomarker Alterations in CTCs Isolated From Patients With MBC

Sponsor
SCRI Development Innovations, LLC (Other)
Overall Status
Completed
CT.gov ID
NCT02436772
Collaborator
(none)
74
Enrollment
1
Location
25.8
Actual Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates the performance of a blood test for detecting biomarkers in metastatic breast cancer patients at one clinic against standard testing.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The primary objective of this pilot study is to detect the expression of FGFR1 and AR on circulating tumor cells (CTCs) isolated from the peripheral blood of metastatic breast cancer (MBC) patients using the OncoCEE™ platform. No procedures will be associated with this study, as these mutations will be evaluated from the leftover blood that has already been sent for standard of care ER and HER2 using the same platform. Results from this testing will be correlated with results obtained from standard testing to calculate the rate of concordance between tests.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    74 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Utilization of the OncoCEE™ Platform to Evaluate Selected Biomarker Alterations in CTCs Isolated From Patients With MBC
    Actual Study Start Date :
    May 13, 2015
    Actual Primary Completion Date :
    Jul 7, 2017
    Actual Study Completion Date :
    Jul 7, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Concordance with standard test [6 months]

      determined by the comparison between OncoCEE test and conventional test

    Eligibility Criteria

    Criteria

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

    • Current patient at participating clinic

    • Metastatic breast cancer diagnosis

    • 18 years of age or older

    Exclusion Criteria:

    None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tennessee Oncology Nashville Tennessee United States 37203

    Sponsors and Collaborators

    • SCRI Development Innovations, LLC

    Investigators

    • Principal Investigator: Erika Hamilton, MD, SCRI

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SCRI Development Innovations, LLC
    ClinicalTrials.gov Identifier:
    NCT02436772
    Other Study ID Numbers:
    • SCRI HEOR_05
    First Posted:
    May 7, 2015
    Last Update Posted:
    Sep 2, 2020
    Last Verified:
    Sep 1, 2020

    Study Results

    No Results Posted as of Sep 2, 2020