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NCT Number: NCT05462795

Liquid Biopsy for Early Non-small Lung Cancer Detection

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.

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Key information

Conditions

Non Small-cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Arizona

Tucson, Arizona, 85724, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liquid biopsy for aberrant DNA methylation analysis - Indeterminate pulmonary nodule

Diagnostic Test

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

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

Diagnostic 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

Liquid biopsy for aberrant DNA methylation analysis - Healthy volunteer

Diagnostic Test

10 cc of blood is collected at one time point

Liquid biopsy for aberrant DNA methylation analysis - Benign lung disease

Diagnostic Test

30 cc of blood is collected at one time point

Primary outcomes

  1. 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.

  2. 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.

  3. Healthy volunteers study cohort

    Time frame: 9 months

    Specificity will be assessed in the normal controls (healthy volunteer cohort) using exact binomial confidence intervals.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Liquid Biopsy to Distinguish Malignant From Benign Pulmonary Nodules and to Monitor Response to Therapy

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2022
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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