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Feasibility of Evaluating Gene Alteration Analysis Using Samples Obtained by EBUS-TBNA in Patients With Lung Cancer

Sponsor
University Health Network, Toronto (Other)
Overall Status
Recruiting
CT.gov ID
NCT01487603
Collaborator
(none)
400
Enrollment
1
Location
144
Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Lung cancer is the leading cause of death in the world. Overall 5-year survival rate is fewer than 10% and the effectiveness of conventional chemotherapy is limited. The new knowledge shows the correlation between genetic alteration and effective of chemotherapy. Therefore non-surgical modalities to obtain tumor specimens for genetic alteration analysis are particularly critical in lung cancer, since many patients have advanced disease at the time of first presentation, and are therefore not eligible for radical surgery. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) samples obtained during diagnosis of lung cancer can be used for molecular analysis that will predict response to treatment and prognosis. In this study, we will detect specific target molecules related to the effectiveness of treatment (surgery, chemotherapy, radiotherapy) and prognosis in patients with lung cancer using EBUS-TBNA samples and its combined with xenograft technology.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Feasibility of Evaluating Gene Alteration Analysis Using Samples Obtained by EBUS-TBNA in Patients With Lung Cancer
    Study Start Date :
    Oct 1, 2011
    Anticipated Primary Completion Date :
    Oct 1, 2023
    Anticipated Study Completion Date :
    Oct 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    confirmed or suspected lung cancer

    Outcome Measures

    Primary Outcome Measures

    1. The primary objective of this study is to perform gene alteration analysis using samples obtained by EBUS-TBNA in lung cancer patients. [5 years]

    Eligibility Criteria

    Criteria

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

    • Age 18 years or older.

    • Patients with confirmed or suspected lung cancer who require EBUS-TBNA as part of their staging investigations of the mediastinum will be considered for the trial.

    • Patients with undiagnosed enlarged lymph nodes in the mediastinum suspicious for lung cancer in which a tissue diagnosis is required.

    Exclusion Criteria:

    • Patients who are deemed on clinical grounds not to be medically fit for a bronchoscopy.

    • Patients where there is a high clinical suspicion of lymphoma.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Health Network Toronto Ontario Canada

    Sponsors and Collaborators

    • University Health Network, Toronto

    Investigators

    • Principal Investigator: Kazuhiro Yasufuku, MD, UHN

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT01487603
    Other Study ID Numbers:
    • 11-0109-CE
    First Posted:
    Dec 7, 2011
    Last Update Posted:
    Apr 11, 2022
    Last Verified:
    Apr 1, 2022
    Keywords provided by University Health Network, Toronto
    Patients
    undiagnosed enlarged
    lymph nodes
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of Apr 11, 2022