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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by University Health Network, Toronto
Information provided by (Responsible Party):
University Health Network, Toronto Identifier:
First received: December 5, 2011
Last updated: December 28, 2016
Last verified: December 2016
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.

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

Resource links provided by NLM:

Further study details as provided by University Health Network, Toronto:

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 ]

Biospecimen Description:

Estimated Enrollment: 400
Study Start Date: October 2011
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
confirmed or suspected lung cancer


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01487603

Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada
Contact: Judy McConnell    416-581-7486      
Contact: Alexandria Grindlay    416-581-7066      
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: Kazuhiro Yasufuku, MD UHN
  More Information

Responsible Party: University Health Network, Toronto Identifier: NCT01487603     History of Changes
Other Study ID Numbers: 11-0109-CE
Study First Received: December 5, 2011
Last Updated: December 28, 2016

Keywords provided by University Health Network, Toronto:
undiagnosed enlarged
lymph nodes

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases processed this record on May 23, 2017