Liquid Biopsy for Early Non-small Lung Cancer Detection

NCT05462795 | Completed DMC

• 2 other identifiers: 2107020697R43CA257133-01A1
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small-cell Lung Cancer

Keywords

Lung cancer; Biomarker; DNA methylation

Outcome Measures

Primary Outcomes (4)

• Indeterminate pulmonary nodule study cohort: Sensitivity and specificity of liquid biopsy test for malignancy

  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.

  9 months

• Known lung cancer for surgical resection study cohort

  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.

  9 months

• Healthy volunteers study cohort

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

  9 months

• Benign lung disease cohort

  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.

  9 months

Study Arms (4)

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

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

Healthy volunteer cohort

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.

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

Benign lung disease cohort

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

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

Interventions

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

Indeterminate pulmonary nodule study cohort

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

Known lung cancer for surgical resection study cohort

Liquid biopsy for aberrant DNA methylation analysis - Healthy volunteer DIAGNOSTIC_TEST

10 cc of blood is collected at one time point

Healthy volunteer cohort

Liquid biopsy for aberrant DNA methylation analysis - Benign lung disease DIAGNOSTIC_TEST

30 cc of blood is collected at one time point

Benign lung disease cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may not qualify if:

• Known lung cancer for surgical resection study cohort
• Healthy volunteer cohort
• Benign lung disease cohort

Sponsors & Collaborators

• University of Arizona: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Study Officials

• Linda Garland, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 18, 2022
• Study Start: August 2, 2022
• Primary Completion: March 22, 2024
• Study Completion: March 22, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)