Liquid Biopsy for Early Non-small Lung Cancer Detection

• Sponsor: University of Arizona (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05462795
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 176
• Location: 1
• Anticipated Duration (Months): 9.9
• Patients Per Site Per Month: 17.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Small-cell Lung Cancer	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 - Healthy volunteer

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 Design

• Study Type: Observational
• Anticipated Enrollment: 176 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Liquid Biopsy to Distinguish Malignant From Benign Pulmonary Nodules and to Monitor Response to Therapy
• Actual Study Start Date: Aug 2, 2022
• Anticipated Primary Completion Date: May 31, 2023
• Anticipated Study Completion Date: May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Indeterminate pulmonary nodule study cohort Patients undergoing a biopsy of an indeterminate lung nodule by surgical excision, bronchoscopic biopsy or Interventional Radiology directed biopsy	Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Indeterminate pulmonary nodule; 10 cc of blood is collected at one time point, which is prior to biopsy procedure
Known lung cancer for surgical resection study cohort Patients with known non-small cell lung cancer who will have surgical resection for treatment	Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Known lung cancer for surgical resection; 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
Healthy volunteer cohort Healthy volunteers with no current known cancer and no history of cancer within 5 years	Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Healthy volunteer; 10 cc of blood is collected at one time point

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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. Description: 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 [9 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona	Tucson	Arizona	United States	85724

Sponsors and Collaborators

• University of Arizona
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Linda Garland, MD, University of Arizona

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Arizona
• ClinicalTrials.gov Identifier: NCT05462795
• Other Study ID Numbers: 2107020697; 1R43CA257133-01A1
• First Posted: Jul 18, 2022
• Last Update Posted: Aug 15, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Arizona: Lung cancer; Biomarker; DNA methylation
• Additional relevant MeSH terms: Lung Neoplasms

Study Results

No Results Posted as of Aug 15, 2022