Clinical trial · Interventional
Utility of Endobronchial Ultrasound Guided Needle Biopsy in Early Stage Non- Small Cell Lung Cancer (NSCLC)
Diagnostic Utility of Endobronchial Ultrasound Guided Mediastinal Lymph Node Sampling in Clinical Stage I and II Non Small Cell Lung Cancer
NCT00832715CI-TRIAL-00023164completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EBUS-TBNA | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EBUS-TBNA
- description
- Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA)
- interventionNames
- Procedure: EBUS-TBNA
Primary outcomes (1)
- measure
- Number of Participants with False Negative Rate Using EBUS Guided Mediastinal Lymph Node Biopsy
- timeFrame
- Patient participation 1 hour to complete EBUS-TBNA
- description
- False negative rate estimated using EBUS guided mediastinal lymph node biopsy following a negative positron emission tomography (PET) scan with a 90% credible interval.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient must be \>/= 18 years old. 2. Patient must have Eastern Cooperative Oncology Group (ECOG)/Zubrod status 0-2. 3. 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). 4. Patient must be eligible for definitive surgical therapy for primary NSCLC. 5. Patient or the patient's legally acceptable representative must provide written informed consent prior to registration and any study-related procedures. 6. 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. 7. All females of childbearing age must have a negative pregnancy test before beginning the study. Exclusion Criteria: 1. Patient has received prior chemotherapy or radiotherapy for this cancer. 2. Patient is considered a poor risk for surgery due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options. 3. Patient has contraindication to either endobronchial ultrasound or mediastinoscopy such as: history of bleeding diathesis, latex allergy, mediastinoscopy, mediastinal nodal resection, tracheostomy. 4. Patients malignancy consistent with well differentiated (carcinoid) neuroendocrine histology. 5. Patient has two separate same histology lung tumors (where the question of two separate primaries or metastatic disease makes definitive clinical staging inaccurate). 6. Females who are pregnant and/or lactating.
References
Publications (0)
Data not yet available
No reference posted for this study.