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临床试验/NCT02559583
NCT02559583已完成不适用

Hemato-Oncology Latin America Observational Registry in CLL, Multiple Myeloma, Non-Hodgkin Lymphoma

Janssen-Cilag Ltd.0 个研究点目标入组 5,443 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5,443
主要终点
Number of Participants with Previous Comorbidities

研究概览

简要总结

The primary purpose of the study is to quantify participants' demographic parameters, country standard therapies, treatment patterns and outcomes among participants with chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) in oncology concentration hospitals in Latin America.

详细描述

This is a retrospective (take a look back at events that already have taken place), non-interventional, multicenter (when more than one hospital or medical school team work on a medical research study) study to review medical records of adult participants with a diagnosis of CLL, MM or NHL anytime since 01 January 2006. Only data available from clinical practice will be collected. All eligible participants at participating centers will be included regardless of participant's demographics, prior or current treatments for disease, or clinical outcome. The period of observation will span from 01 January 2006 through present, but all eligible participants must be followed for a minimum of 1 year, unless the participant died within that first year. Participant demographic parameters, standard therapies, treatment patterns and outcomes will be primarily quantified.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of chronic lymphocytic leukemia (CLL), multiple myeloma (MM), or non-Hodgkin lymphoma (NHL) anytime since January 1, 2006
  • At least one year of data following first observed diagnosis except in the case of the participant death within one year following first observed diagnosis
  • Participant must sign a participation agreement/informed consent form (ICF)

排除标准

  • Having one and only one consult in the center

结局指标

主要结局

Number of Participants with Previous Comorbidities

时间窗: 1 year

Comorbidities included: heart, diabetes, hypertension, renal, infections, other neoplasia, neurologic, rheumatologic, HIV, thrombosis, bone and other.

Number of Participants as per treatment therapy received

时间窗: 1 year

Cancer treatment (Chronic Lymphocytic Leukemia \[CLL\], Multiple Myeloma \[MM\] and non-Hodgkin lymphoma \[NHL\]) for all participants is summarized by the number of participants who had any type of surgery or radiotherapy (external radiation or brachytherapy) or other drug treatments.

Overall survival

时间窗: 1 year

Overall Survival (OS) was defined as the time from date of starting treatment to death due to any cause.

Number of Participants with Response to Treatment

时间窗: 1 year

Number of participants who responded to treatment is presented. Treatment response will be assessed based on complete response or partial response.

次要结局

  • Incidence Percentage of Participants with Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM) and non-Hodgkin lymphoma (NHL)(1 year)
  • Prevalence Percentage of Participants with CLL, MM and NHL(1 year)

研究者

申办方类型
Industry
责任方
Sponsor

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