Clinical trial NCT05462795: Liquid Biopsy for Early Non-small Lung Cancer Detection
Official title: Liquid Biopsy to Distinguish Malignant From Benign Pulmonary Nodules and to Monitor Response to Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small-cell Lung Cancer
Keywords: Lung cancer
Biomarker
DNA methylation
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-07-18
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_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).

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.

Eligibility 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

Primary outcomes:
measure: Indeterminate pulmonary nodule study cohort: Sensitivity and specificity of liquid biopsy test for malignancy
timeFrame: 9 months
measure: Known lung cancer for surgical resection study cohort
timeFrame: 9 months
measure: Healthy volunteers study cohort
timeFrame: 9 months
measure: Benign lung disease cohort
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Linda Garland, MD
role: PRINCIPAL_INVESTIGATOR
References: