Pilot study to assess the efficacy and validation of a QPCR test for Auxiliary Diagnosis of High Prevalence Cancers using whole blood mRNA

Cancer remains a leading cause of morbidity and mortality worldwide, with many cases diagnosed at advanced stages when treatment is less effective. Early detection significantly improves patient outcomes. This pilot study aims to validate a novel QPCR-based leukocyte mRNA biomarker test for auxiliary diagnosis of nine high-prevalence cancer types including breast, lung, colorectal, esophageal, pancreatic, oral, cervical, hepatic, and gastric cancers. The test measures immunosuppression through peripheral blood mononuclear cell derived leukocyte mRNA biomarkers, providing a minimally invasive alternative to conventional imaging and liquid biopsy methods. Approximately 50 diagnosed cancer patients (stages 1-4) aged 18-80 years will be enrolled. Blood samples will be collected at screening, processed for RNA extraction, cDNA synthesis, and qPCR analysis. The primary outcome is sensitivity and specificity of the assay measured by delta delta Ct values normalized against GAPDH. Secondary outcomes include accuracy in cancer type identification and biomarker expression changes correlating with treatment response and disease progression. This study is expected to demonstrate the diagnostic potential of PBMC-based biomarkers and establish a standardized clinical pathway for integration of this auxiliary diagnostic tool into routine cancer care, ultimately improving early detection and patient outcomes.