Improving early detection of melanoma with skin self examination

描述(申请人提供)：早期发现是提高黑色素瘤存活率的关键：较薄的病灶(较早发现)的预后比较厚的(较晚发现的)好得多-在加利福尼亚州，0.75 mm肿瘤的10年存活率为98%，而3.99 mm肿瘤的10年存活率仅为48%。在所有厚度的黑色素瘤中，黑色素瘤的发病率都在迅速上升，这意味着特别的筛查努力并没有对黑色素瘤产生影响，黑色素瘤目前在男性最常见的癌症中排名第四，在女性中排名第五。据我们所知，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一直无法就筛查黑色素瘤的好处提出建议。我们的目标是提供有关皮肤自检(SSE)有效性的数据。我们将重点放在SSE上，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，可能也是无效的。SSE提供了一个以最低成本及早发现黑色素瘤的机会，而且有迹象表明，消息灵通的人可以像非专科医生一样容易地发现黑色素瘤。上证所的随机干预研究从未进行过。我们已经成功地试行了SSE，并获得了评估SSE有效性的数据，这些数据有力地表明，SSE可以很容易地在人口基础上采用。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。我们将对SSE在检测南加州凯撒永久医疗系统(KPSC)成员的病变方面的准确性(敏感性和特异性)进行研究。我们将比较个体对自己的雀斑的评估(使用SSE)与癌症前病变的临床证据，使用全身皮肤检查和全身数字成像，针对两种流行情况，以及18个月后新的和变化的病变，记录发生及时后续护理的情况。这种方法有许多优势：(1)我们将检查SSE发现流行和事件情况的能力，将SSE的使用与黄金标准(使用最先进的数字成像进行医生验证)进行比较，目前尚未完成；(2)使用KPSC的电子病历数据将最大限度地减少(或完全避免)随访损失；(3)如果它被证明是准确的，SSE可以立即在KPSC人群中进行随机对照试验，然后被KPSC用于预防黑色素瘤和NMSC。南加州KPSC有数百万人口，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.