BACKGROUND. It has already been shown that the production of fucosylceramide, an aberrant glycolipid, is associated with neoplastic changes in human tissues. The authors of this study designed a sandwich radioimmunoassay (RIA) using a mouse monoclonal anti-fucosylceramide antibody, PC47H, designated as PC/PC RIA, and measured the level of u-FCC, an antigen of PC47H, in the urine of cancer patients. METHODS. The cohort comprised 41 patients with gastric carcinoma, 35 with colorectal carcinoma, 34 with other malignancies, 14 with cholelithiasis, 18 with gastric ulcer, and 110 healthy individuals. The u-FCC was quantified by PC/PC RIA. The cutoff value of u-FCC was obtained from the 110 healthy individuals, and the rates of positivity for gastric and colorectal carcinoma patients were evaluated. RESULTS, The rates of u-FCC positivity were 63% for patients with gastric carcinoma and 69% for colorectal carcinoma patients. The rate was only 1% (1/110) for the healthy individuals. The u-FCC value did not correlate with the values of either CA 19-9 or carcinoembryonic antigen (CEA). In a combination assay of u-FCC with CA 19-9 and CEA, the positivity rates were 84% for gastric carcinoma patients and 85% for colorectal carcinoma patients. CONCLUSIONS. Gastric and colorectal carcinoma patients have significantly high levels of u-FCC in their urine compared with normal individuals. Cancer 1998;83: 660-5. (C) 1998 American Cancer Society.