Liquid Biopsy for Early Non-small Lung Cancer Detection

Completed

• Conditions: Non Small-cell Lung Cancer
• Interventions: Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Healthy volunteer; Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Indeterminate pulmonary nodule; Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Known lung cancer for surgical resection; Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Benign lung disease

• Registration Number: NCT05462795
• Lead Sponsor: University of Arizona

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 Timeline

• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-13
• Study First Posted: 2022-07-18
• Study Start: 2022-08-02
• Primary Completion: 2024-03-22
• Study Completion: 2024-03-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteer cohort	Liquid biopsy for aberrant DNA methylation analysis - Healthy volunteer	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.
Indeterminate pulmonary nodule study cohort	Liquid biopsy for aberrant DNA methylation analysis - Indeterminate pulmonary nodule	Patients undergoing a biopsy of an indeterminate lung nodule by surgical excision, bronchoscopic biopsy or Interventional Radiology directed biopsy
Known lung cancer for surgical resection study cohort	Liquid biopsy for aberrant DNA methylation analysis - Known lung cancer for surgical resection	Patients with known non-small cell lung cancer who will have surgical resection for treatment
Benign lung disease cohort	Liquid biopsy for aberrant DNA methylation analysis - Benign lung disease	Patients with the following categories of benign lung disease: * COPD/emphysema * Granulomatous infection * Interstitial lung disease including pulmonary fibrosis and interstitial lung disease.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

University of Arizona; 🇺🇸 Tucson, Arizona, United States