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临床试验/NCT02589548
NCT02589548Unknown不适用

Brazilian Prospective Hodgkin Lymphoma Registry

Universidade Federal do Rio de Janeiro1 个研究点 分布在 1 个国家目标入组 1,400 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,400
试验地点
1
主要终点
Overall Survival

研究概览

简要总结

The study is a prospective registry of Hodgkin Lymphoma (HL) patients in Brazil.

The purpose of the study is to gather clinical, epidemiologic and outcomes data on the treatment of HL, on the basis of records collected by key Brazilian institutions, through a centralized web-based registry of clinical data verified by central board of hematopathologists.

详细描述

Hodgkin Lymphoma is considered one of the malignancies with highest cure rates. Its prognosis improved substantially along the last three decades, as a result of relevant cooperative studies carried out in American and European institutions. Around 70-80% of the patients are cured with the available chemotherapy regimens.

However, data about HL in developing countries are scarce. It is well established that patients in underprivileged societies present with malignancies in more advanced stages. In studies of HL patients treated in Brazil during the 80's, most patients presented with advanced disease.

The creation of registry of patients with HL will provide a more reliable picture of the disease in the country, its prevalence in different areas and socioeconomic groups, and treatment outcomes. It will also foster the establishment of a network among hospitals in all regions of the country, which may serve as a platform for further development of cooperative studies engaging the main Brazilian Institutions.

The data collection allows comparison of data entered into the registry against predefined rules for range or consistency with other data fields in the registry. Also, quality assurance addresses data validation and data analysis. Standard descriptive analyses will be carried out. For a crude association analysis, categorical data will be analysed using the chi-square or Fisher's exact test (two-sided). Survival curves will be estimated using the Kaplan-Meier method and compare using the log-rank test. Univariate and multivariate Cox regression analyses will be conducted to verify the prognostic factors regarding Progression free survival and Overall survival, adjusted for relevant prognostic clinical variables and treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
12 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Previously untreated HL patients
  • Clinical data including baseline information on disease localization and laboratory parameters at staging, features of treatment adopted and assurance of follow-up updating for at least 5 years are requested
  • Written informed consent

排除标准

  • 未提供

结局指标

主要结局

Overall Survival

时间窗: 5 years

Overall Survival

次要结局

  • Event Free survival(5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Irene Biasoli

Associate Professor

Universidade Federal do Rio de Janeiro

研究点 (1)

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