Improving early detection of melanoma with skin self examination

描述（由申请人提供）：早期发现是提高黑色素瘤存活率的关键：较薄的病变（发现较早）比较厚的病变（发现较晚）预后好得多——在加州，小于0.75mm肿瘤的10年生存率为98%，而小于3.99mm肿瘤的10年生存率仅为48%。黑素瘤的发病率在所有厚度的黑素瘤中都在迅速增加，这意味着特别的筛查工作对黑素瘤没有影响，黑素瘤目前是男性中第四大最常见的癌症，在女性中排名第五。我们知道加州没有正式的活动来评估黑色素瘤筛查干预措施的影响和有效性，但由于数据不足，美国预防服务工作组无法就黑色素瘤筛查的益处提出建议。我们的目的是提供关于皮肤自检（SSE）有效性的数据。我们之所以关注SSE，是因为基于人群的医生发起的黑色素瘤筛查已被证明是不切实际的，而且可能无效。SSE提供了早期发现黑色素瘤的机会，成本最低，而且适应症是消息灵通的个人可以像非专业医生一样容易发现黑色素瘤。从未进行过SSE的随机干预研究。我们已经成功地对SSE进行了试点，并获得了评估SSE有效性的数据，这些数据强烈表明SSE可以很容易地在人口基础上被采用。然而，我们需要证明SSE可以准确地识别问题病变，并随后寻求适当的治疗。我们将在Kaiser Permanente Southern California （KPSC）医疗保健系统的成员中进行SSE检测病变的准确性（敏感性和特异性）研究。我们将比较个体对自身痣的评估（使用SSE）与癌前病变的临床证据，使用全身皮肤检查和18个月时的全身数字成像，包括普遍情况和新发和变化的病变，记录及时随访护理的发生情况。这种方法有很多优点：(1)我们将检查SSE发现流行和意外情况的能力，将SSE的使用与金标准（使用最先进的数字成像进行医生验证）进行比较，这是迄今为止尚未完成的；(2)使用KPSC的电子病历数据将最大限度地减少（或完全避免）对随访的损失；(3)如果证明SSE是准确的，可以立即在KPSC人群中进行随机对照试验，然后将SSE用于KPSC预防黑色素瘤和NMSC。南加州KPSC人口数百万，是世界上黑色素瘤风险最高的人群之一。

DESCRIPTION (provided by applicant): Early detection is the key to improving melanoma survival: thinner lesions (found earlier) have a much better prognosis than thicker lesions (found later) - in California melanoma survival rates are 98% at 10 years with <0.75mm tumors, but only 48% at 10 years with >3.99mm tumors. Melanoma incidence is increasing rapidly across all thicknesses of melanomas, implying that ad hoc screening efforts are not having an impact on melanoma, which is now the 4th most common cancer among males and 5th among females. We are aware of no formal activities in California to assess the impact and effectiveness of screening interventions for melanoma, yet the US Preventive Services Task Force has been unable to make a recommendation regarding the benefit of screening for melanoma because of insufficient data. We aim to provide data on the effectiveness of skin self examination (SSE). We are focusing on SSE because population-based physician-initiated melanoma screening has been shown to be impractical and probably ineffective. SSE offers an opportunity to find melanomas early, with minimal cost, and indications are that well-informed individuals can find melanomas just as easily as non- specialist physicians. A randomized intervention study of SSE has never been conducted. We have successfully piloted the SSE and have obtained data assessing the efficacy of SSE that strongly suggest SSE can be readily adopted on a population basis. However, we need to demonstrate that SSE can accurately identify problem lesions, and that appropriate care will subsequently be sought. We will conduct a study of the accuracy (sensitivity and specificity) of SSE in detecting lesions in members of the Kaiser Permanente Southern California (KPSC) Health Care system. We will compare an individual's assessment of their own nevi (using SSE) to clinical evidence of precancerous lesions using full body skin exams and whole body digital imaging for both prevalent conditions, and new and changing lesions at 18 months, documenting the occurrence of timely follow-up care. This approach has many advantages: (1) we will examine SSE's ability to find BOTH prevalent and incident conditions, comparing SSE use to a gold standard (physician verification using state-of-the-art digital imaging), not accomplished to date; (2) loss to follow-up will be minimized (or completely avoided) using electronic medical records data from KPSC; (3) should it be shown to be accurate, the SSE could be immediately tested in a randomized controlled trial in the KPSC population, and then adopted by KPSC for the prevention of melanoma and NMSC. Southern California KPSC is a population of millions, among those at highest melanoma risk in the world.