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 February 2013 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01487603
First received: December 5, 2011
Last updated: February 5, 2013
Last verified: February 2013
  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

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 ] [ 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
Study Population

Patients with lung cancer

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.
  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 ClinicalTrials.gov identifier: NCT01487603

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada
Contact: Judy McConnell    416-581-7486      
Contact: Frances Allison    416-340-5446      
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014