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临床试验/NCT01395615
NCT01395615已完成不适用

Utility Measurement Study for Patients With Chronic Lymphocytic Leukaemia

Hoffmann-La Roche0 个研究点目标入组 34 人开始时间: 2008年10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
34
主要终点
Quality of life: EuroQol Group EQ-5D questionnaire

研究概览

简要总结

This observational study will assess the health related quality of life (HQRL) profiles of patients with chronic lymphocytic leukaemia. Using health assessment questionnaires, data will be collected from patients currently receiving therapy and from those who have finished therapy and have undergone an assessment of 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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients, >/= 18 years of age
  • Patients with chronic lymphocytic leukaemia
  • Patients receiving 1st line therapy
  • Patients receiving 2nd line therapy. This will include patients who previously have responded well to 1st line therapy (relapse was >12 months after finishing the 1st line therapy) and are receiving the same therapy again
  • Within the past three months, patients whose treatment has been stopped after 2-3 cycles of 1st or 2nd line therapy and who have not received any further therapies
  • Patients receiving their 3rd, 4th, 5th or 6th cycle of 1st or 2nd line therapy
  • Patients who have completed therapy, are considered stable and are between 3-12 months post therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1

排除标准

  • Clinically significant disorder (other than chronic lymphocytic leukaemia and chronic lymphocytic comorbidities) or any other condition, including alcohol or drug abuse, which may interfere with study participation or affect study conclusions
  • Mental disability or significant mental illness, legal incapacity or limited legal capacity
  • Current high degree of comorbid burden that might affect the accuracy of the quality of life data

结局指标

主要结局

Quality of life: EuroQol Group EQ-5D questionnaire

时间窗: 18 months

Quality of life: European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire

时间窗: 18 months

Quality of life: EORTC QLQ-CLL16 (chronic lymphocytic leukaemia) questionnaire

时间窗: 18 months

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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