A description was provided of the development of a clinical protocol currently in use by the Drake Health Registry Study (DHRS). The DHRS was established to screen persons at high risk of developing bladder cancer due to possible occupational exposure to the bladder carcinogen, beta-naphthylamine (91598) (BNA). The Drake Chemical Company operated in Lock Haven, Pennsylvania from 1940 until 1981, at which time the site was designated a hazardous waste site. This was one of the few sites in the United States where BNA was manufactured. A total of 408 former employees has been identified. Of these, 42 died before notification of the investigation. Of the 366 eligible for the screening program, 162 have registered. Eligible employees were provided a battery of screening tests based on a voided urine specimen. The current protocol consists of a two tiered screening schedule and has been utilized successfully for 15 months. Of the 26 results to date, most were based on abnormal Papanicolaou cytology and or quantitative fluorescence image analysis. Bladder abnormalities were cited among most of the 18 study members who underwent diagnostic evaluation, including chronic cystitis, inflammation, hyperplasia, and dysplasia. The authors concluded that the screening program is detecting very early changes in a relatively young cohort and that these persons must be monitored over a number of years to ensure adequate medical surveillance.
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