Spots Global Cancer Trial Database for Risk Stratification of Patients Using the Lung Cancer Biomarker Panel in China

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Trial Identification

Brief Title: Risk Stratification of Patients Using the Lung Cancer Biomarker Panel in China

Official Title: Multicenter Study for Risk Stratification of Patients Presenting With Symptoms Related to Lung Cancer Using the Lung Cancer Biomarker Panel (LCBP) in China

Study ID: NCT01928836

Conditions

Lung Neoplasms

Interventions

Study Description

Brief Summary: The purpose of this study is to verify clinical utility of a simple blood test comprising of four protein- based markers for risk stratification of patients presenting symptoms related to lung cancer.

Detailed Description: The study is a multicenter, prospective case-control research. Totally 1,200 cases will be collected in the hospitals, with 600 cases in control group, which are not suspected as lung cancer from chest CT, and other 600 in suspected group. When inclusion into the two groups, clinical information and 10mL blood sample of the patient will be recorded and tested for cancer biomarkers, biochemical detection and cardiovascular disease biomarkers, etc. The correlation between cancer biomarker panel, CT scan result and clinical pathological diagnosis will be investigated through cases follow up. The sample size estimated above was set up according to sensitivity and specificity of biomarkers in pre-study, based on lung cancer incidence of the population. To compare the diagnostic accuracy among different cancer biomarkers through T-test, Mann-Whitney U and receiver operating characteristic (ROC) curve with SPSS 15.0 software. In statistic analysis, 0.05 is set as the p value for significance. Effectiveness of the four biomarkers panel in lung cancer diagnoses and staging will be analyzed.