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Liquid Biopsy for Early Non-small Lung Cancer Detection

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University of Arizona

Status

Active, not recruiting

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
1R43CA257133-01A1 (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

Trial contacts and locations

1

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Central trial contact

Linda Garland, MD

Data sourced from clinicaltrials.gov

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