Prospective Collection of Data in Patients With T-cell Lymphomas Distributed in the Five Distinct Macro Regions of Brazil
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 主要终点
- Descriptive analysis during the first year of T-cell Brazil Registry
研究概览
简要总结
The designed study follows up on the previous one by the international T-cell project (Bellei et al,, 2012) and its purpose is to verify whether a prospective collection of data would permit access to more accurate information permitting a better definition of prognosis and investigation of more adequate treatment strategies for these neoplasms.
The analysis of patients distributed in all five macro regions of the country and a comparison among them will provide a real picture of the disease in Brazil, limiting the bias probably found in the previous projects.
详细描述
Patients with diagnosis histologically confirmed T-cell or NK-cell lymphoma will be registered in the study, despite of their planned treatment. Registration will be made on-line on a key restricted accessible web-database after obtaining the informed consent dated and signed by the patient. Every registered patient has as well to undergo a central histopathology review by a panel of experts. The referring pathologist will collect and review the patological material sent by the participating centers, without knowing the clinical outcome of the patient. Validated cases have to be supplied of information regarding treatment procedures and follow up updating for at least 5 years. The primary endpoint is the overall survival and other endpoints such as event free survival; progression free survival, complete and partial response rates.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dated and signed informed consent;
- •T-cell or NK-cell diagnosis;
- •Tissue biopsies adequate for diagnosis and classification and available for centralized review;
- •clinical, laboratory, image data available and registred in the website.
排除标准
- 未提供
结局指标
主要结局
Descriptive analysis during the first year of T-cell Brazil Registry
时间窗: 12 months of registring
Descriptive analysis and Overall survival
次要结局
未报告次要终点