跳至主要内容
临床试验/NCT05882175
NCT05882175招募中不适用

A Prospective Study to Validate the Prognostic Power of the Optimized HLH Inflammatory (OHI) Index

Meir Medical Center2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
2
主要终点
To assess 365 days mortality of OHI+ and OHI- patients

研究概览

简要总结

Hemophagocytic lymphohistiocytosis (HLH) associated with hematologic malignancies (HM-HLH) is a syndrome with an abysmal prognosis (10-30% 5 years overall survival). The investigators have recently established an improved diagnostic and prognostic index for HM-HLH, termed the Optimized HLH Inflammatory (OHI) index. The OHI index is comprised of the combined elevation of soluble CD25 (sCD25) > 3,900 U/mL and ferritin >1,000 ng/mL . However, the true incidence and outcomes of HLH/OHI+ in an unselected cohort are unknown, and so is the mechanism of HM-HLH.

详细描述

The investigators will enroll patients with new/transformed hematologic malignancies. The investigators will follow the patients until the end of the study, report their survival at one year and examine their prognosis.

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
是

入选标准

  • •Patients with hematologic malignancies
  • •At least 18 years old

排除标准

  • •Prior recent treatment (chemotherapy/ other cytoreductive therapies in the last month)

结局指标

主要结局

To assess 365 days mortality of OHI+ and OHI- patients

时间窗: Mortality rate one year from OHI assessment

The investigators will use Kaplan-Meier curves to compare survival between OHI+ and OHI- patients

次要结局

  • To determine the incidence of OHI+ patients in our cohort(The investigators will assess the incidence after three years of enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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