跳至主要内容
临床试验/NCT04375579
NCT04375579进行中(未招募)不适用

Multi-domain Assessment and Quality of Life in Patients Older Than 60 Years Receiving an Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Assistance Publique - Hôpitaux de Paris18 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2020年7月3日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
205
试验地点
18
主要终点
Overall survival

研究概览

简要总结

Patients older than 60 years are more and more transplanted. Comprehensive geriatric assessment (CGA) have been developed and are currently used in patients with cancer, it has been correlated with the prognosis. There is still few data in transplanted patients and the aim of this study is to assess these patients before and after transplantation in order to monitor their general health and quality of life (QOF) and correlate them to the prognostic.

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 60 years or more at time of transplantation
  • Patient receiving a hematopoietic stem cell allograft for myeloid hemopathy (myeloid acute leukemia, myelodysplastic syndrome, Myeloproliferative neoplasm) or for an Acute lymphoblastic leukemia
  • No opposition to participate

排除标准

  • Patient opposed to the protocol
  • Vulnerable patients protected by curatorship or administrative supervision
  • Patients not covered by a social security scheme

结局指标

主要结局

Overall survival

时间窗: at one year post allogeneic hematopoietic stem cell transplantation

次要结局

  • Acute graft-versus-host disease(at 100 days)
  • Length of hospitalisation during the first year after graft(Up to one year)
  • Questionnaire completion rate(At 2 years)
  • Evaluation of Quality of life(at one year)
  • Length of pre-grafting visit(At 2 years)
  • Walk test(at two years)
  • Karnofsky index(at one year)
  • Length of hospitalisation initially(at two years)
  • Overall survival(at two years post allogeneic hematopoietic stem cell transplantation)
  • Survival without disease and chronic graft-versus-host disease(at two years post allogeneic hematopoietic stem cell transplantation)
  • Length of 1year visit(At 2 years)
  • Morbidity Index(at two years)
  • Proportion of patient with Viral Reactivation(at one year)
  • Chronic graft-versus-host disease(at 2 years)
  • Incidence of relapse(at two years)
  • Evaluation of autonomy(at one year)
  • Length of D100 visit(At 2 years)
  • Nutritional score(at two years)
  • Length of 2 years visit(At 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (18)

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