There are a wide variety of tumor markers now available that proved to be o
f value in the management of cancer patients. Of these markers, tissue poly
peptide antigen (TPA) and tissue polypeptide specific antigen (TPS) are wel
l known in the field of bladder cancer. TPA was found to be a mixture of cy
tokeratins 8, 18 and 19 and recent investigations proved that TPS is kerati
n 18. The aim of the present study was to assess the clinical value of urin
ary cytokeratin 19 (CYFRA21-1) in the differential diagnosis between bladde
r cancer and benign urinary tract diseases represented by bilharziasis. Two
hundreds and seventy individuals were included in the present study: 186 w
ith bladder cancer representing the different stages and grades, 44 with ur
inary tract bilharziasis and 40 normal healthy controls. CYFRA21-1 was eval
uated in 24-hour urine samples by ELISA using the automatic set supplied by
Boehringer Manheim, Manheim, Germany (ES 300). Results of this study revea
led significant elevation of CYFRA21-1 in bladder cancer followed by bilhar
ziasis. 82.3% (153/186) of bladder cancer patients and 11.4% (5/44) of bilh
arzial patients exhibited CYFRA21-1 levels above the upper limit of the con
trol group (3 mu g/24-hr). CYFRA21-1 was more sensitive in advanced than ea
rly stages of bladder cancer and in patients with positive than those with
negative lymph nodes, but association of tumor with bilharziasis did not ma
rkedly affect its level.