The long-term objective is to establish the role of urinary hCG free beta-subunit and beta-fragment as clinical markers for the common gynecologic cancers. CLINICAL OBJECTIVES a) To determine the proportion of patients with gynecologic cancer having elevated urinary hCG free beta-subunit or beta- fragment titers. We propose examining titers in fluids from 80- 100 subjects/yr with newly diagnosed cancer. b) To examine the use of urinary free beta-subunit and beta- fragment as markers for progression of chemotherapy (1-4 regimens, 10-12 subjects/yr each) and radiotherapy (10-12 patients/yr). c) To evaluate the use of these markers in following cervical cancer by measuring titers in urines from patients with precancerous cervical changes (100/yr). Urines will also be collected from patients attending the general gynecology clinic (500-700/yr) to correlate free beta-subunit and beta-fragment titers with Pap smear screening to see if the former will function as an alternative or back-up assay to the Pap smear. OTHER OBJECTIVES a) To develop a single immunoassay for quantitating total urinary beta-subunit (hCG plus free beta-subunit and beta-fragment) for use in cancer detection. b) To investigate the origins of beta-fragment (the principal form of beta-subunit in urines). Molecules in cancer tissues (10-20 surgical specimens/yr) will be compared with beta-fragment in urine by immunoassays and gel filtration. PILOT STUDIES Parallel urines and sera were examined from 42 subjects with active gynecologic cancers, and hCG, free beta-subunit and beta- fragment (found only in urine) measured using immunoassays. Consistent with the serum studies of others, we found 19% of subjects positive for hCG or free beta-subunit. In urine, however, 73% of patients had elevated free beta-subunit or beta-fragment titers (includes 25% with hCG). Over 70% of patients with early disease (stage I or II) had elevated titers. Average titers of urinary beta-fragment were, on a molar basis, 7 -fold greater than those of serum hCG. In a control study of 16 healthy subjects, 1 had a low-positive urinary beta-fragment titer. The efficacy of free beta-subunit and beta-fragment as screeing markers for gynecologic malignancies and for determining response to therapy will be further evaluated.
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