COLLABORATIVE OCULAR MELANOMA STUDY - CLINICAL CENTER

眼部黑色素瘤合作研究 - 临床中心

• 批准号: 3551620
• 负责人: CLEMENT L TREMPE
• 金额: $ 2.93万
• 依托单位: SCHEPENS EYE RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 1985
• 资助国家: 美国
• 起止时间: 1985-09-30 至 1990-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3551620
• 关键词: cooperative study; eye disorder diagnosis; eye neoplasms; human mortality; human subject; human therapy evaluation; longitudinal human study; metastasis; neoplasm /cancer diagnosis; neoplasm /cancer radiation therapy; patient care management; prognosis; radiation hazard; retina disorder; vision tests; visual perception

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. Commplications of irradiation and changes in visual acuity will be documented and monitored carefully throughout follow-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 an 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 or 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 standardized forms will be used in all centers. Central training and certification of all study staff will be required.

本研究是一项多中心、随机、对照临床试验