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Interrogation of Wnt, Notch and Hedgehog Activity in Primary Tumor Samples

Sponsor
University of Miami (Other)
Overall Status
Terminated
CT.gov ID
NCT02006550
Collaborator
(none)
227
Enrollment
1
Location
100.3
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cancer results when undifferentiated cells grow in an uncontrolled manner, crowding out normal cells, causing morbidity and ultimately mortality. The cancer stem cell theory suggests that most tumors undergo a process of differentiation through which a relatively rare cancer stem or progenitor cell (CSC) gives rise to more differentiated populations of cells (including transiently amplifying cells) comprising the bulk of the tumor. As a result of this cellular diversity, one or more cells within the tumor are likely to be resistant to therapy. Among cells resistant to a given therapy, only CSCs can repopulate the tumor. A key feature of this resistant subset of CSCs is that they repopulate a tumor resistant to the original intervention. The cellular programs driving the uncontrolled proliferation of many solid tumors result from aberrant activity of Wnt, Shh, and/or Notch signaling pathways in CSC. Thus, therapies that down-regulate the activity of these fundamental pathways in CSCs will be effective in the treatment of cancer. The investigators' research program focuses on the elucidation of signaling mechanisms, control of cellular processes and discovery of small molecules that selectively target Wnt, Shh, and Notch signaling pathways that are fundamental to CSCs. Our preliminary results identified a novel Notch associated protein NACK that functions as a transcriptional co-activator of Notch. Moreover, Nack is expressed in human solid tumors and is required for cell survival and tumor growth in notch -dependent tumor cells. The investigators' aim is to further interrogate the link between Notch and Nack.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    227 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Interrogation of Wnt, Notch and Hedgehog Activity in Primary Tumor Samples
    Actual Study Start Date :
    Jun 16, 2010
    Actual Primary Completion Date :
    Oct 25, 2018
    Actual Study Completion Date :
    Oct 25, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Identify and isolate the cancer stem cell populations from primary tumor samples. [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients diagnosed with a primary cancer tumor scheduled for a surgery to remove it.
    Exclusion Criteria:
    • Patients not diagnosed with a primary cancer scheduled for a standard of care (SOC) surgery.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Miami Miami Florida United States 33136

    Sponsors and Collaborators

    • University of Miami

    Investigators

    • Principal Investigator: Anthony Capobianco, PhD, University of Miami

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anthony Capobianco, Professor, University of Miami
    ClinicalTrials.gov Identifier:
    NCT02006550
    Other Study ID Numbers:
    • 20100200
    First Posted:
    Dec 10, 2013
    Last Update Posted:
    Apr 1, 2019
    Last Verified:
    Mar 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Anthony Capobianco, Professor, University of Miami
    Wnt
    Notch
    Hedgehog
    Tumor Sample

    Study Results

    No Results Posted as of Apr 1, 2019