Liquid Biopsy for Early Non-small Lung Cancer Detection

University of Arizona

Status: Completed

Conditions: Non Small-cell Lung Cancer

Treatments: Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Healthy volunteer; 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; Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Indeterminate pulmonary nodule

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05462795

R43CA257133-01A1 (U.S. NIH Grant/Contract)

2107020697

Details and patient eligibility

About

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.

Full 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.

Enrollment: 171 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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
• Exclusion criteria: N/A

Healthy volunteer cohort

• Inclusion criteria: Healthy persons
• Exclusion criteria: No known current cancer or history of cancer within 5 years

Benign lung disease cohort

• Inclusion criteria: Patients with the following categories of benign lung disease: COPD/emphysema, Granulomatous infection, Interstitial lung disease including pulmonary fibrosis and interstitial lung disease.
• Exclusion criteria: N/A

Trial design

171 participants in 4 patient groups

Indeterminate pulmonary nodule study cohort

Description:

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

Treatment:

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

Known lung cancer for surgical resection study cohort

Description:

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

Treatment:

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

Healthy volunteer cohort

Description:

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.

Treatment:

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

Benign lung disease cohort

Description:

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

Treatment:

Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Benign lung disease