Recruiting

Gene Alteration Analysis

Sponsor:

University Health Network, Toronto

Code:

NCT01487603

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT01487603

Start date

Oct, 2011

Status verified date

Apr, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

confirmed or suspected lung cancer

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Judy McConnell

judy.mcconnell@uhn.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada

Contacts

Judy McConnell

416-581-7486

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

  • Patients
  • undiagnosed enlarged
  • lymph nodes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-05-04.