SECONDARY PREVENTION OF LIVER CANCER IN HAIMEN, CHINA

中国，海门县原发性肝癌二级预防 原发性肝细胞癌(PHC)导致25万至100万人死亡 每年在全球范围内，中国每年有10到20万人。五年制 症状后确诊的原发性肝癌患者的存活率 出现率为5%。外科手术切除小的、无症状的肿瘤， 然而，已经产生了高达67%的五年生存率。因为 其他治疗方法并未改变存活率，早期发现小(&lt； 直径3厘米)肿瘤，然后手术切除是唯一的 改善这些患者预后的有效方法。 慢性乙肝病毒(乙肝病毒)感染与约80%的 肝癌。用血清甲胎蛋白监测乙肝病毒携带者 (AFP)用于检测早期PHCS的水平已用于 阿拉斯加土生土长的人，在美国临床医生广泛使用。在……里面 亚洲，临床医生使用实时超声(US)进行筛查 PHC。尽管美国既是一个更敏感、更具体的缩写 筛查试验优于AFP，US筛查不可行 医院外的大量人员。法新社报道 AFP升高者的初步筛查方法为 很实用。然而，从来没有过一项适当的对照试验 AFP单独筛查或与US联合筛查的疗效。只有一个 前瞻性的对照临床试验，遵循被监测的 而不受监测的队列将能够辨别出 这些筛查方式。 因此，我们设计了一项AFP筛查的对照试验 由美国为PHC的早期检测，将在高度 江苏省海门县中国病区。两个队列 在5000名男性和2500名女性乙肝病毒携带者中，有一人被监测为6- 每隔一个月，将研究其他未监测(通常护理)的情况 五年了。我们将检验以下假设： 1.被监测的人死于PHC的死亡率将降低50% 与未受监测的队列相比。 2.PHC死亡率的降低将导致全因死亡率的下降 未监测队列的死亡率。 3.在监测队列中，60%的筛查发现病例 会有孤立的可切除肿瘤。在不受监控的人群中 队列&lt；10%的PHC将是孤立的可切除的病变。 4.筛查程序AFP的预测值为阳性 接下来是美国的筛查，将是75%。敏感度和 筛查计划的特异度将为80%。 此外，PHC自然历史的以下参数将 被估计： A.通过筛查获得的诊断提前期。 B.可检测到的临床前阶段的长度。 C.筛查发现的进展为 临床癌症。

Secondary Prevention of Primary Liver Cancer in Haimen County, China Primary hepatocellular carcinoma (PHC) causes 250,000 to 1,000,000 deaths annually worldwide and 100,000 to 200,000 per year in China. Five-year survival rates for patients with PHC who are diagnosed after symptoms appear are < 5%. Surgical resection of small, asymptomatic tumors, however, has yielded five-year survival rates as high as 67%. Because other therapies have not changed survival, early detection of small (< 3 cm in diameter) tumors followed by surgical resection is the only available method of improving the outcome of these patients. Chronic hepatitis B virus (HBV) infection is associated with ~80% of liver cancers. Monitoring HBV carriers with serum alpha-fetoprotein (AFP) levels for the detection of early stage PHCs has been used among Alaskan natives and is widely practiced by clinicians in the USA. In Asia, clinicians use real time ultrasonography (US) for screening for PHC. Although US is both a more sensitive and more specific initial screening test than AFP, it is not feasible to apply US screening to large numbers of persons outside of a hospital setting. AFP as the initial screening method followed by US of persons with elevated AFPs is practical. However, there has never been a properly controlled trial of the efficacy of AFP screening alone or in combination with US. Only a controlled clinical trial which prospectively follows both a monitored and unmonitored cohort will be able to discern the ultimate efficacy of these screening modalities. Therefore, we have designed a controlled trial of AFP screening followed by US, for the early detection of PHC, to be carried out in a highly endemic area of China, Haimen County in Jiangsu Province. Two cohorts of 5000 male and 2500 female HBV carriers each, one monitored at six- month intervals, the other unmonitored (usual care) will be studied for five years. The following hypotheses will be tested: 1. The monitored will have a > 50% reduction in mortality from PHC compared with the unmonitored cohort. 2. Decreased mortality from PHC will cause reduction in all-cause mortality of the unmonitored cohort. 3. Among the monitored cohort, > 60% of the screening detected cases of PHC will have solitary resectable tumors. Among the unmonitored cohort < 10% of the PHCs will be solitary resectable lesions. 4. The predictive value positive of the screening program, AFP screening followed by US, will be > 75%. The sensitivity and specificity of the screening program will be > 80%. In addition, the following parameters of the natural history of PHC will be estimated: a. The lead time in diagnosis gained by screening. b. The length of the detectable pre-clinical phase. c. The proportion of screening detected tumors that progress to clinical cancers.