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Cancer Associated Macrophage-Like (CAML) Cells to Enhance Detection of Early Stage Lung Cancer and Relapse after Definitive Treatment


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The hypothesis of this study is that Cancer Associated Macrophage Like cells (CAMLs) can enrich for the presence of malignancy in patients with pulmonary nodules. Specific Aims: 1. Determine the prevalence of CAMLS (+/- CTCs) in patients with indeterminate pulmonary nodules.; 2. Determine the positive and negative predictive value of CAMLS in patients with pulmonary nodules who undergo biopsy.; 3. Model combinations of clinical factors with the presence/absence of CAMLs to refine strategies for assessment of patients with pulmonary nodules. Subjects will be drawn from pulmonary nodule and thoracic surgery clinics at the Fox Chase Cancer Center (FCCC) and VA Philadelphia (VA). CAMLs will be evaluated at the time of clinically indicated scans and correlated with the presence or absence of cancer. Patients with biopsy confirmed lung cancer within 12 months of the CAML test will be defined as "diseased"; otherwise, they will deemed as "disease free". Positive and negative predictive value of the test will be determined. Logistic regression will be used to assess the utility of this test after accounting for clinical factors and nodule characteristics. To date, the study has been activated and is accruing patients at FCCC and is undergoing IRB review at the VA.



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