Feasibility of Evaluating Gene Alteration Analysis Using Samples Obtained by EBUS-TBNA in Patients With Lung Cancer
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Purpose
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 |
|---|
|
Lung Cancer |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Feasibility of Evaluating Gene Alteration Analysis Using Samples Obtained by EBUS-TBNA in Patients With Lung Cancer |
- The primary objective of this study is to perform gene alteration analysis using samples obtained by EBUS-TBNA in lung cancer patients. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Biospecimen Description:
Tissue.
| Estimated Enrollment: | 400 |
| Study Start Date: | October 2011 |
| Estimated Primary Completion Date: | October 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| confirmed or suspected lung cancer |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with lung cancer
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| Canada, Ontario | |
| University Health Network | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Judy McConnell 416-581-7486 | |
| Contact: Frances Allison 416-340-5446 | |
| Principal Investigator: | Kazuhiro Yasufuku, MD | UHN |
More Information
No publications provided
| Responsible Party: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT01487603 History of Changes |
| Other Study ID Numbers: | 11-0109-CE |
| Study First Received: | December 5, 2011 |
| Last Updated: | February 5, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University Health Network, Toronto:
|
Patients undiagnosed enlarged lymph nodes |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013