Utility of CAML as Diagnostic for Early Stage Lung Cancer

Study Overview
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Brief Summary
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Primary Objective Determine the prevalence of CAMLS in patients with pulmonary nodules. Secondary Objectives Determine the positive and negative predictive value of CAMLS in patients with pulmonary nodules who undergo biopsy. Model combinations of clinical factors with the presence/absence of CAMLS to refine strategies for assessment of patients with pulmonary nodules. Evaluate whether these measures result in enhanced T-cell activity and/or NK cell function and number

Official Title
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TH-146: Cancer Associated Macrophage-Like (CAML) Cells to Enhance Detection of Early Stage Lung Cancer

Conditions
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Pulmonary Nodule, Multiple, Pulmonary Nodule, Solitary

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Referral for a pulmonary nodule that has not yet been biopsied and that meets the definition of an indeterminate nodules (i.e. 0.8-3.0 cm). No prior diagnosis of lung cancer or other invasive malignancy within the past 5 years. No history of rheumatologic disease. Age > 18 years. Ability to understand and willingness to sign a written informed consent and HIPAA consent document Exclusion Criteria: Patients with active, known or suspected autoimmune disease. Prior diagnosis of lung cancer or other invasive malignancy within the past 5 years. Uncontrolled intercurrent illness that would increase the risk of toxicity or limit compliance with study requirements. This includes but is not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Known HIV-positive patients on combination antiretroviral therapy are ineligible because of the abnormal immune response that results from HIV disease (testing is not required). Patients should be excluded if they are known to be positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection (testing is not required). Subjects with any history of interstitial lung disease or a history of > or = to grade 2 radiation pneumonitis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of prevalence pf CAMLs in Pulmonary modules | Laboratory studies performed on blood drawn at Creatv Microtech will determine the prevalence of CAMLS in pulmonary nodules. | During the first 2 years of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of positive and negative predictive value, sensitivity and specificity of CAMLS in patients with pulmonary nodules who undergo biopsy | Positive Predictive Value and Negative Predictive Value, sensitivity and specificity at the initial screen will be computed for the entire study population. | Through study completion, an average of 3 years | 
| Model combinations of clinical factors with the presence/absence of CAMLs to refine strategies for assessment of patients with pulmonary nodules. Evaluate whether measures result in enhanced T-cell activity/Natural Killer (NK) cell function and number | Bidimensional measurements of lung nodules done by a radiologist or pulmonary physician from CT scans with 5mm (or less) cuts, using lung windows in the axial plane | Through study completion, a maximum of 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAML, Early Detection