- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00372203
Endobronchial Ultrasound vs Mediastinoscopy in NSCLC
Prospective Controlled Trial of Mediastinoscopy Compared With Endobronchial Ultrasound Guided Transbronchial Needle Aspiration for Assessment of the Mediastinum in Lung Cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2C4
- University Health Network (Toronto General Hospital)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
A) Age 18 years or older B) Patients with confirmed or suspected non-small cell lung cancer who require a mediastinoscopy as part of their staging investigations of the mediastinum to determine suitability for lung cancer resection will be considered for the trial.
C) Patients with undiagnosed enlarged lymph nodes in the mediastinum suspicious for lung cancer in which a tissue diagnosis is required.
Exclusion Criteria:
A) Patients who are deemed on clinical grounds not to be medically fit for a bronchoscopy or a mediastinoscopy or who are not suitable for definitive surgical resection by thoracotomy will be excluded.
B) Patients who have verified stage IV disease or who are not appropriate for lung cancer resection by virtue of direct invasion of mediastinal structures or large parts of the chest wall.
C) Known small cell lung cancer. D) Patients where there is a high clinical suspicion of lymphoma. E) Inability to give informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Endobronchial ultrasound
|
Endobronchial Ultrasound Guided Transthoracic Needle Biopsy of mediastinal lymph nodes at the time of the mediastinoscopy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sensitivity
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
Investigators
- Principal Investigator: Shaf Keshavjee, MD MSc FRCSC FACS, University Health Network, Toronto
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-0085-A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Endobronchial Ultrasound Guided Transthoracic Needle Biopsy
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National Taiwan University HospitalUnknownMediastinal Lymphadenopathy | Tuberculous Mediastinal LymphadenopathyTaiwan
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Poitiers University HospitalCompletedEndobronchial Transbronchial Needle Aspiration Lung Cancer Procore
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Ohio State University Comprehensive Cancer CenterRecruiting
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Western University, CanadaCompletedLung Cancer | Thoracic Cancer | Mediastinal LymphadenopathyCanada
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Royal Brompton & Harefield NHS Foundation TrustHeidelberg University; Chelsea and Westminster NHS Foundation TrustWithdrawnLymphoma | Carcinoma | Sarcoidosis | Mediastinal Lymphadenopathy | Hilar Lymphadenopathy | Mycobacterial DiseaseUnited Kingdom, Germany
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Mayo ClinicNational Cancer Institute (NCI)Recruiting
-
University Health Network, TorontoRecruitingSuspected SarcoidosisCanada
-
M.D. Anderson Cancer CenterRecruiting