To investigate the sensitivity of the CA 125 immunoradiometric assay for occult ovarian neoplasia, serum CA 125 levels were retrospectively determined "blind" in specimens collected from 105 women who subsequently developed ovarian neoplasia, and from 323 matched controls. The distribution of CA 125 levels was very different between the case and control populations (p = 0.0001) over the entire collection-to-diagnosis interval (range 1-143 months). Median CA 125 levels for all cases, and for those collected more than 24, 36 or even 60 months prior to diagnosis, were always 18 U/ml or greater, compared with a median of 10.9 U/ml for controls. Half of the cases collected within the 18 months preceding diagnosis had CA 125 levels of more than 30 U/ml and one-third had levels greater than 65 U/ml. About one-fourth of those collected prior to 60 months before diagnosis had levels above 30 U/ml. In contrast, approximately 7% and 0.9% of controls had levels in excess of 30 or 65 U/ml, respectively. Elevations occurred in cases eventually diagnosed with localized or advanced cancer, and with borderline or obviously malignant disease. These results provide an insight into the preclinical biology of ovarian neoplasia that may help in designing methods for early detection of this disease, and demonstrate the usefulness of the JANUS serum bank as a resource in evaluating serum tests.

Carcinoembryonic antigen was determined before treatment in 101 patients with adenocracinoma of the uterus. If 2 5 ng/ml is accepted as the upper normal value, 34% of the patients with cancer of the corpus had elevated levels. Only 7% had values exceeding 5 ng/ml. The highest recorded value in endometrial carcinoma was 8.5 ng/ml. In adenocarcinoma of the cervix 68% had values over 2.5 ng/ml and a direct correlation between nodal metastases and plasma elevation of CEA was found. The highest recorded value for endocervical cancer was 108 ng/ml. No patient with localized disease had a value over 4.0 ng/ml. It is concluded that adenocarcinomas of the cervix and corpus have different biological properties, and that in adenocarcinoma of the cervix determination of CEA is a reliable indicator of the extent of disease.

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