This clinical trial will assess the performance of a liquid biopsy assay to identify cancer in indeterminant pulmonary nodules identified by CT screening of high-risk individuals and evaluate the capability of the liquid biopsy assay to monitor response to surgical resection.
This clinical study examines the feasibility of a liquid biopsy methylation assay to detect non-small lung cancer. First, the investigators will apply their liquid biopsy assay to screen for lung cancer in indeterminate pulmonary nodules suspicious for cancer. Second, the investigators will assess the utility of liquid biopsy to assess tumor dynamics after surgical resection with curative intent. Third, the investigators will assess the presence or absence of this methylation assay in healthy normal persons without a history of lung cancer.
Study Type
OBSERVATIONAL
Enrollment
171
10 cc of blood is collected at one time point, which is prior to biopsy procedure
10 cc of blood is collected at three time points: 1) before surgery; 2) 4-6 weeks post surgery; and 3) 6 months post surgery
University of Arizona
Tucson, Arizona, United States
Indeterminate pulmonary nodule study cohort: Sensitivity and specificity of liquid biopsy test for malignancy
The patients with indeterminate nodules will be used to separately estimate the sensitivity (in those with lung cancer) and specificity (in those without lung cancer). At least 35 patients with lung cancer will provide an estimate of the standard error of the sensitivity \< 0.09. Specificity will also be assessed in the normal controls (healthy volunteer cohort) using exact binomial confidence intervals.
Time frame: 9 months
Known lung cancer for surgical resection study cohort
To determine the correlation between the longitudinal marker levels and time to progression, to allow adjustment for relevant clinical characteristics. Correlations between change in the methylation results and response to therapy using radiographic findings (response, stable disease, progression) at 6 months post-baseline time point will be analyzed using a multinomial regression model.
Time frame: 9 months
Healthy volunteers study cohort
Specificity will be assessed in the normal controls (healthy volunteer cohort) using exact binomial confidence intervals.
Time frame: 9 months
Benign lung disease cohort
Thirty-five patients with benign lung disease will provide an estimate of the standard error of the specificity \<0.09. Assuming a specificity value of 0.91 (32 negative/35 total), the exact 95% confidence interval is (0.77, 0.98). The specificity will be estimated separately, with an exact 95% confidence interval, for each of the benign lung disease subtypes as an exploratory analysis.
Time frame: 9 months
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10 cc of blood is collected at one time point
30 cc of blood is collected at one time point