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Using a new radioimmunometric assay for a monoclonal antibody-defined tumor marker, CA19-9, we evaluated its clinical usefulness. CA19-9 RIA kits (Centocor) were used to determine the concentration of this antigen in sera of patients with malignant diseases (166), benign diseases (75) and of healthy subjects (90). We studied also the correlation between the serum levels of this antigen and other tumor markers, POA and CEA.Elevated serum levels of CA19-9 were found in 83% of pancreatic cancer and biliary tract cancer as well, 100% of cholangioma, 40% of hepatocellular carcinoma, 39% of gastric cancer. The elevated circulating level of CA19-9 was also observed in patients with chronic pancreatitis (20%), cholelithiasis (76%), liver cirrhosis (8%), gastric ulcer (13%) and renal failure (47%). The serum value of this CA19-9 bore no relation to any one of POA or CEA. A patient of localized pancreatic cancer with tumor size less than 2cm in diameter had the circulating CA19-9 value within normal range, but 2 other patients with successful resectable pancreatic cancer had each a raised value before operation, with reservation to normal range after operation. This antigen was considered to be useful for monitoring the therapeutic effects on cancer patients. These results suggest that this antigen is one of the most useful tumor markers for carcinoma of the pancreas or the biliary tarct.