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The proteolytic part of CK-19, referred to as CYFRA21-1, is detected as a soluble molecule in serum and other body fluids, and it has been measured as a tumor marker in several neoplastic diseases.To examine whether urinary or/and serum sample CYFRA21-1 could be the biomarker for bladder cancer, we conducted a comprehensive meta-analysis of 3 case-control studies.All studies considered, patients with bladder cancer had a higher CYFRA21-1 level than healthy people.In the subgroup analysis, we found that patients with bladder cancer metastatic disease had a higher CYFRA21-1 level than patients with bladder cancer Locally invasive disease.However, no significant difference was found between patients with bladder cancer Locally(Histological stages Ⅰ)disease and patients with bladder cancer Locally(Histological stages Ⅱ)disease in CYFRA21-1 levels.Patients with bladder cancer locally(Histological stages Ⅱ)disease and patients with bladder cancer locally(Histological stages Ⅲ)disease have no significant difference in CYFRA21-1 levels.In conclusion,CYFRA21-1 level could be a diagnostic biomarker for the diagnosis of bladder cancer, a possible biomarker for differentiation between bladder cancer Locally invasive and bladder cancer metastatic, but it could not be the urinary or serum biomarkers for the differential histological stages of bladder cancer Locally (Histological grade Ⅰ to Ⅲ)disease.