Non Small-cell Lung Cancer
Conditions
Keywords
Lung cancer, Biomarker, DNA methylation
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTLiquid biopsy for aberrant DNA methylation analysis - Indeterminate pulmonary nodule
10 cc of blood is collected at one time point, which is prior to biopsy procedure
DIAGNOSTIC_TESTLiquid biopsy for aberrant DNA methylation analysis - Known lung cancer for surgical resection
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
DIAGNOSTIC_TESTLiquid biopsy for aberrant DNA methylation analysis - Healthy volunteer
10 cc of blood is collected at one time point
DIAGNOSTIC_TESTLiquid biopsy for aberrant DNA methylation analysis - Benign lung disease
30 cc of blood is collected at one time point
Sponsors
National Cancer Institute (NCI)
University of Arizona
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Indeterminate pulmonary nodule study cohort * Inclusion criteria: Patients undergoing a biopsy of an indeterminate lung nodule by surgical excision, bronchoscopic biopsy or Interventional Radiology directed biopsy *
Exclusion criteria
No known concurrent cancer Known lung cancer for surgical resection study cohort * Inclusion criteria: Patients with known non-small cell lung cancer who will have surgical resection for treatment *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Indeterminate pulmonary nodule study cohort: Sensitivity and specificity of liquid biopsy test for malignancy | 9 months | 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. |
| Known lung cancer for surgical resection study cohort | 9 months | 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. |
| Healthy volunteers study cohort | 9 months | Specificity will be assessed in the normal controls (healthy volunteer cohort) using exact binomial confidence intervals. |
| Benign lung disease cohort | 9 months | 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. |
Countries
United States
Outcome results
None listed