Non Small-cell Lung Cancer Clinical Trial
Official title:
Liquid Biopsy to Distinguish Malignant From Benign Pulmonary Nodules and to Monitor Response to Therapy
Verified date | April 2024 |
Source | University of Arizona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Arizona | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
University of Arizona | National Cancer Institute (NCI) |
United States,
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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