跳至主要内容
临床试验/NCT00481858
NCT00481858已完成不适用

A CLL Research Consortium (CRC) Phase II Study of Kinetic Biomarker for Chronic Lymphocytic Leukemia (CLL) Prognosis

KineMed5 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2005年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
5

研究概览

简要总结

This project will attempt to validate the utilization of a stable isotope kinetic biomarker (KineMarkerTM) as a predictive test for disease progression in early stage chronic lymphocytic leukemia (CLL).

详细描述

Chronic Lymphocytic Leukemia (CLL), the most common leukemia in the western world, is characterized by a pathological expansion of leukemic B cells. The clinical course of CLL is remarkably heterogeneous; some patients have relatively aggressive disease requiring early treatment, others have highly indolent disease that does not require current anti-leukemia therapy until many years after diagnosis. Current staging systems have not been able to predict which patients in early or intermediate risk stages will undergo disease progression and which will undergo an indolent course. Universal treatment of all patients with early stage disease has been shown to be more harmful than beneficial. As such, early identification of patients who will have more aggressive disease soon after diagnosis has been a major goal in CLL research.

In response to this need for a reliable prognostic marker, KineMed is investigating the use of CLL kinetics as a biomarker for subsequent disease progression. This test assesses B-Cell kinetics directly through an in vivo kinetic measurement of tumor DNA synthesis and catabolism by combining 2H2O labeling and state of the art analytic instrumentation.

研究设计

研究类型
Observational
观察模型
Cohort

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

  • >18 years of age
  • clinical diagnosis of chronic lymphocytic leukemia
  • diagnosis within previous 3 years
  • Stage 0, I, or II disease
  • willingness and capacity to give informed consent

排除标准

  • current or prior cll treatment
  • serious co-morbid medical condition
  • patient likely to need treatment in the next 16 weeks
  • pregnancy

研究者

发起方
KineMed
申办方类型
Industry

研究点 (5)

Loading locations...

相似试验