Nutritional Prevention of Cancer Sample Clauses

Nutritional Prevention of Cancer. (NPC) Trial The Nutritional Prevention of Cancer (NPC) trial is a randomized double-blind, placebo-controlled clinical trial to evaluate the long term safety and efficacy of daily 200-µg supplement of selenium (Se) in preventing two types of skin cancers: basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). From 1983 through 1991, a total of 1,312 patients with previous histories of BCC or SCC were recruited and randomized into the treatment group in which patients were supposed to take daily 200-µg supplement of selenium (Se), or the control group in which placebo pills were given. Patients were then followed for a period of over twelve years. Follow up visits to clinics were scheduled for every 6 months or more frequent if necessary to exam for new dermatological problems or selenium toxicity. The primary end points of this trial were new occurrences of BCC or SCC. Possible censoring events include death and end of routine dermatological exams. Xxxxx et al. (1996) reported an adverse but statistically non-significant effect of selenium supplement in prevention of new occurrence of BCC or SCC. Their findings are contrary to prior expectation since highly significant positive benefits were found on selenium supplement in preventing a number of other types of cancers. The findings of Xxxxx et al. (1996) might be contributed to two reasons. First, they did not consider recurrent BCC or SCC. During the study, each patient might experience multiple occurrences of BCC or SCC. But in the analysis, they considered only time to the first occurrence of BCC or SCC. Second, the baseline plasma Se level as an important prognostic risk factor for BCC and SCC is subject to substantial measurement error. But the authors did not consider the possible effect of measurement error on statistical analysis. One natural question arises is how to incorporate these additional information of time to multiple occurrences of BCC or SCC and consistently estimate the covariate effect for recurrent events data under the circumstance of covariate measurement error. We will develop methods in Chapter 2 to address this question.
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