PROSPECTIVE-STUDY OF CAM 17-CENTER-DOT-1 WGA MUCIN ASSAY FOR SEROLOGICAL DIAGNOSIS OF PANCREATIC-CANCER/

Background Serological tests for pancreatic cancer are little used, pa rtly because such assays have proved insufficiently specific for scree ning. However, retrospective studies have reported results that compar e well with commonly used scanning techniques. In this prospective stu dy we assessed a new type of combined lectin/antibody enzyme-linked mu cin assay, CAM 17.1, in a routine clinical setting. Methods Clinicians at a 1200-bed teaching hospital were encouraged to request the CAM 17 .1 assay for any patient whose differential diagnosis included pancrea tic cancer. Serum samples from 250 patients were tested during an 18-m onth period. Patients were followed up for at least 8 months. 75 patie nts who did not have symptoms of pancreatic cancer and had alternative diagnoses were also studied as a control group. Findings Of the 250 p atients, 36 had pancreatic cancer, as defined by histological and imag ing criteria, and eight of these patients had a resectable tumour. The sensitivity and specificity of the CAM 17.1 assay were 86% and 91%, r espectively, in all patients, 85% and 81% in those who presented with jaundice, and 89% and 94% in patients who did not have jaundice. The s ensitivity of the assay compared well with that of ultrasound scanning (59%) and computed tomography (83%) in these patients. Use of the CAM 17.1 assay in combination with ultrasonography allowed identification of 94% of patients with pancreatic tumours and ail of those with rese ctable tumours. CAM 17.1 binding activity did not correlate with tumou r size. Interpretation Our study confirms the usefulness of the CAM 17 .1 tumour-marker assay for the diagnosis of pancreatic cancer. Serolog ical mucin assays should be used more widely in combination with ultra sonography in the investigation of non-jaundiced patients with unexpla ined abdominal pain or weight loss.