Utility of Endobronchial Ultrasound Guided Needle Biopsy in Early Stage Non- Small Cell Lung Canc… (NCT00832715) | Clinical Trial Compass
CompletedPhase 1/2
Utility of Endobronchial Ultrasound Guided Needle Biopsy in Early Stage Non- Small Cell Lung Cancer (NSCLC)
United States120 participantsStarted 2009-04
Plain-language summary
The goal of this clinical research study is to learn how accurately an endobronchial ultrasound transbronchial needle aspiration (EBUS -TBNA) may detect mediastinal lymph node metastases in patients with clinical stage I and II non-small cell lung cancer (NSCLC).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient must be \>/= 18 years old.
✓. Patient must have Eastern Cooperative Oncology Group (ECOG)/Zubrod status 0-2.
✓. Patient must have proven or suspected NSCLC (squamous cell, adenocarcinoma, or large cell) and be clinical Stage I or II, according to the 1998 staging system of the American Joint Commission on Cancer for lung cancer (T1-3 N0, T1-2 N1).
✓. Patient must be eligible for definitive surgical therapy for primary NSCLC.
✓. Patient or the patient's legally acceptable representative must provide written informed consent prior to registration and any study-related procedures.
✓. If the patient is a survivor of a prior invasive cancer, all of the following criteria must apply: a. Patient has undergone potentially curative therapy for all prior malignancies. b. No evidence of active / recurrent disease.
✓. All females of childbearing age must have a negative pregnancy test before beginning the study.
Exclusion criteria
✕. Patient has received prior chemotherapy or radiotherapy for this cancer.
✕. Patient is considered a poor risk for surgery due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
✕. Patient has contraindication to either endobronchial ultrasound or mediastinoscopy such as: history of bleeding diathesis, latex allergy, mediastinoscopy, mediastinal nodal resection, tracheostomy.
What they're measuring
1
Number of Participants with False Negative Rate Using EBUS Guided Mediastinal Lymph Node Biopsy
Timeframe: Patient participation 1 hour to complete EBUS-TBNA
✕. Patients malignancy consistent with well differentiated (carcinoid) neuroendocrine histology.
✕. Patient has two separate same histology lung tumors (where the question of two separate primaries or metastatic disease makes definitive clinical staging inaccurate).