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Molecular Analysis of Oncogenes and Resistance Mechanisms in Lung Cancer

Sponsor
University of Colorado, Denver (Other)
Overall Status
Recruiting
CT.gov ID
NCT01580982
Collaborator
(none)
175
Enrollment
1
Location
156.3
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The mechanisms of sensitivity and resistance to oncogene-targeted therapy can be determined from tumor tissue or tumor cell lines derived from available archival samples and/or from standard-of-care re-biopsy upon suspected tumor progression.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    To identify baseline and treatment-related somatic changes in the tumor tissue from patients with lung and other thoracic cancers. To estimate the proportion of patients that subsequent therapy is altered based on the information acquired from such biopsies.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    175 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Molecular Analysis of Oncogenes and Resistance Mechanisms in Lung and Other Thoracic Cancers
    Actual Study Start Date :
    Jan 23, 2012
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Jan 30, 2025

    Outcome Measures

    Primary Outcome Measures

    1. To identify baseline and treatment-related somatic changes in the tumor tissue from patients with lung and other thoracic cancers. [To be determined upon funding]

    Secondary Outcome Measures

    1. To estimate the proportion of patients that subsequent therapy is altered based on the information acquired from such biopsies [To be determined upon funding]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients undergoing investigation or treatment for thoracic cancers with oncogene-targeted therapies

    2. Aged 18 years or older

    3. Either a) have suspected tumor progression or other condition that dictates a standard-of-care palliative, therapeutic, or diagnostic intervention including but not limited to procedures such as bronchoscopic biopsy, computed tomography (CT) or ultra-sound (US)-guided biopsy, thoracentesis, video assisted thoracoscopic (VATS) pleurodesis, lobectomy, adrenalectomy or pleural catheter placement, providing tumor specimen appropriate molecular analysis or b) have previously had biopsy/surgical intervention with tumor tissue at University of Colorado or an outside institution available for medullar analysis.

    4. Patients must have the ability to understand and willingness to sign an informed consent document.

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado Cancer Center Aurora Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver

    Investigators

    • Principal Investigator: Robert C. Doebele, MD, PhD, University of Colorado, Denver

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT01580982
    Other Study ID Numbers:
    • 11-1621.cc
    First Posted:
    Apr 19, 2012
    Last Update Posted:
    Oct 29, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by University of Colorado, Denver
    Oncogenes
    Lung and Other Thoracic Cancers
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of Oct 29, 2021