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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05462795
Other study ID # 2107020697
Secondary ID 1R43CA257133-01A
Status Active, not recruiting
Phase
First received
Last updated
Start date August 2, 2022
Est. completion date October 2, 2024

Study information

Verified date April 2024
Source University of Arizona
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 171
Est. completion date October 2, 2024
Est. primary completion date October 2, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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
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
Liquid biopsy for aberrant DNA methylation analysis - Healthy volunteer
10 cc of blood is collected at one time point
Liquid biopsy for aberrant DNA methylation analysis - Benign lung disease
30 cc of blood is collected at one time point

Locations

Country Name City State
United States University of Arizona Tucson Arizona

Sponsors (2)

Lead Sponsor Collaborator
University of Arizona National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Healthy volunteers study cohort Specificity will be assessed in the normal controls (healthy volunteer cohort) using exact binomial confidence intervals. 9 months
Primary 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
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