Lung Carcinoma
Conditions
Brief summary
This trial studies how well endobronchial ultrasound-guided transbronchial needle-aspiration (EBUS-TBNA) with suction works in obtaining samples from patients with suspected lung cancer that has spread to the nodal. EBUS-TBNA samples obtained with additional suction may help to improve material-amounts and decrease blood contamination in the samples.
Detailed description
PRIMARY OBJECTIVES: I. To evaluate if suction applied with a vacuum syringe during EBUS-TBNA sampling helps to obtain more material for molecular analyses. OUTLINE: Patients undergo bronchoscopy with EBUS-TBUA first without and then with applied vacuum.
Interventions
PROCEDUREBronchoscopy
Undergo bronchoscopy with EBUS-TBNA
Undergo bronchoscopy with EBUS-TBNA
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Computed tomography (CT)-scan finding suspicious for lung cancer with nodal metastases * Clinically stable to undergo diagnostic workup by bronchoscopy with endobronchial ultrasound
Exclusion criteria
* Pregnant female * Minors * Prisoners * Patients with contraindication for EBUS such as non-reversible anticoagulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of samples collected via endobronchial ultrasound-guided transbronchial needle-aspiration with suction | Up to 3 years | The qualitative data will have a set number of variable to follow and will be converted to quantitative data. Data will be analyzed using Microsoft Excel, SAS, or SPSS. After checking the normality of the data, all non-parametric data will be converted to parametric data. Appropriate tests for categorical and continuous data will be used. Categorical variables will be compared using Chi-square or Fisher?s Exact test. Normally distributed variables will be compared using Student-T-test and one way analysis of variance. Non-parametric test will include Mann Whitney U test and Kruskal Wallis test. A two tailed p value of \< 0.05 will be considered significant.Sample weight (microgram) and visual blood contamination score (0 = no visible blood, 1 = light red shading, 2 = red shading) of endobronchial needle aspiration biopsies obtained with and without suction. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPeter Kneuertz, MD
Ohio State University Comprehensive Cancer Center
Outcome results
None listed