COLLABORATIVE OCULAR MELANOMA STUDY-CLINICAL CENTER

建议的研究是一项多中心、随机、对照的临床试验。 设计用于比较脉络膜黑色素瘤患者的眼球摘除术和 放射治疗后在存活的基础上诊断和治疗。 这项研究的候选对象将是新诊断的脉络膜病例 黑色素瘤1只眼，身高大于3毫米，直径达18毫米乘8毫米 年满21岁且无转移疾病证据的体型 年纪更大了。在治疗之前，必须征得所有患者的知情同意。 随机化。所有患者将接受至少十年或 直到死亡。主要关注的结果是各种原因造成的死亡。 次要结果将包括死于癌症，无论是转移性或 不是，还有其他肿瘤的诊断。放射治疗的并发症和 视力的变化将被记录下来并仔细监测 在接下来的时间里。 这项研究将在全国各地的临床中心进行。 从主要人口中心吸引病人的美国；a 协调中心；眼底图片阅读中心；病理学 中心和声学中心。预计每个临床中心将 每年至少招收12名符合条件的患者。这项研究将指导 由12至15名研究调查员和一名 负责处理日常业务决策的指导委员会。一个 独立的数据和安全监测委员会将负责 确保研究的合乎道德的进行，并审查 定期积累数据，以获得不利或有益的证据 治疗的效果。 调查人员的意图是收集和分析HIGH数据 质量将为以下问题提供确凿的答案 脉络膜视网膜病变患者的治疗选择 黑色素瘤。标准化的临床和数据收集程序将是 所有中心都将使用标准化的表格。中环 将需要对所有研究人员进行培训和认证。

The proposed study is a multicenter, randomized, controlled clinical trial designed to compare enucleation of eyes with choroidal melanomas with irradiation on the basis of survival after diagnosis and treatment. Candidates for the study will be newly diagnosed cases with choroidal melanoma in one eye greater than 3 mm in height and up to 18 mm by 8 mm in size and with no evidence of metastatic disease who are 21 years of age or older. Informed consent will be obtained from all patients prior to randomization. All patients will be followed for a minimum of ten years or until death. The outcome of primary interest is death from all causes. Secondary outcomes will include death from cancer, whether metastatic or not, and diagnosis of other tumors. Complications of irradiation and changes in visual acuity will be documented and monitored carefully throughout folow-up. The study will be conducted in clinical centers located throughout the United States which draw patients from the major population centers; a Coordinating Center; a Fundus Photograph Reading Center; a Pathology Center; and a Sonography Center. Each clinical center will be expected to enroll at least 12 eligible patients each year. The study will be directed by a Executive Committee consisting of 12 to 15 study investigators and a Steering Committee to deal with day-to-day operational decisions. An independent Data and Safety Monitoring Committee will be responsible for assuring the ethical conduct of the study and for reviewing the accumulating data on a regular basis for evidence of adverse or beneficial effects of therapy. The intention of the investigators is to collect and analyze data of high quality which will provide a conclusive answer to the question of therapeutic preference in the management of patients with choroidal melanomas. Standardized clinical and data collection procedures will be employed, and standarized forms will be used in all centers. Central training and certification of all study staff will be required.