Feasibility of Evaluating Gene Alteration Analysis Using Samples Obtained by EBUS-TBNA in Patients With Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Canada · 1 center
- University Health Network — Toronto
Identifiers
NCT: NCT01487603 · 11-0109-CE