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Outcome Measures

Primary Outcomes (4)

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.
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.
9 months
Healthy volunteers study cohort
Specificity will be assessed in the normal controls (healthy volunteer cohort) using exact binomial confidence intervals.
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.

Study Arms (4)

Indeterminate pulmonary nodule study cohort

Patients undergoing a biopsy of an indeterminate lung nodule by surgical excision, bronchoscopic biopsy or Interventional Radiology directed biopsy

Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Indeterminate pulmonary nodule

Known lung cancer for surgical resection study cohort

Patients with known non-small cell lung cancer who will have surgical resection for treatment

Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Known lung cancer for surgical resection

Healthy volunteer cohort

Healthy volunteers with a) no current diagnosis of cancer; b) no history of cancer over the last 5 years; and c) no existing known benign lung disease that is currently requiring treatment with medication.

Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Healthy volunteer

Benign lung disease cohort

Patients with the following categories of benign lung disease: * COPD/emphysema * Granulomatous infection * Interstitial lung disease including pulmonary fibrosis and interstitial lung disease.

Interventions

Liquid biopsy for aberrant DNA methylation analysis - Indeterminate pulmonary noduleDiagnostic test

10 cc of blood is collected at one time point, which is prior to biopsy procedure

Indeterminate pulmonary nodule study cohort

Liquid biopsy for aberrant DNA methylation analysis - Known lung cancer for surgical resectionDiagnostic test

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients and volunteers will be recruited from the BUMC-T Pulmonary and UACC clinics (Indeterminate pulmonary nodule); through study posting on ClinicalTrials.gov and word of mouth (Healthy volunteers); UACC Thoracic Surgery Clinic (Pre-post lung cancer surgery); and Pulmonary Clinic (Benign Lung Disease).

You may not qualify if:

Known lung cancer for surgical resection study cohort

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosis

Liquid Biopsy for Early Non-small Lung Cancer Detection

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (4)

Indeterminate pulmonary nodule study cohort

Known lung cancer for surgical resection study cohort

Healthy volunteer cohort

Benign lung disease cohort

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (4)

Indeterminate pulmonary nodule study cohort

Known lung cancer for surgical resection study cohort

Healthy volunteer cohort

Benign lung disease cohort

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations