Liquid Biopsy to Distinguish Malignant From Benign Pulmonary Nodules and to Monitor Response to Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Arizona
- Enrollment
- 171
- Locations
- 1
- Primary Endpoint
- Known lung cancer for surgical resection study cohort
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Known lung cancer for surgical resection study cohort
Time Frame: 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
Time Frame: 9 months
Specificity will be assessed in the normal controls (healthy volunteer cohort) using exact binomial confidence intervals.
Indeterminate pulmonary nodule study cohort: Sensitivity and specificity of liquid biopsy test for malignancy
Time Frame: 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.
Benign lung disease cohort
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported