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

NCT01487603 | Recruiting

• 1 other identifier: 11-0109-CE
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Patients; undiagnosed enlarged; lymph nodes

Outcome Measures

Primary Outcomes (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

Study Arms (1)

confirmed or suspected lung cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lung cancer

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, Canada

RECRUITING

Biospecimen

Tissue.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kazuhiro Yasufuku, MD

  UHN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judy McConnell

CONTACT

judy.mcconnell@uhn.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 7, 2011
• Study Start: October 1, 2011
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

CA (1)