Could Ki-67 be Used as a Diagnostic or Prognostic Marker in Hemato-oncological Diagnostics?
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Maturation patterns diagnosis
研究概览
简要总结
Ki-67 is used as a marker for determination of the proliferative activity in solid tumors. The use within hemato-oncological malignancies is limited. This is related to limited technical possibilities of flow cytometry in the past. Meanwhile, flow cytometry in hemato-oncological malignancies has progressed to assessment of 8 colors and makes it possible to add Ki-67 as an additional marker to the 8-color panels. Adding Ki-67 to these panels could lead to improved diagnosis and prediction of therapy response for a number of hemato-oncological malignancies.
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
- 否
入选标准
- •MDS and AML patients
排除标准
- •Ongoing radio- and/or chemotherapy
结局指标
主要结局
Maturation patterns diagnosis
时间窗: 5 years
Maturation patterns based on immunophenotype for red blood cells and several types of immune cells and their respective contributions to diagnosis. Maturation patterns are scored by various methods/combinations to form diagnostic score. A higher diagnostic score will lead to a more likely diagnose for MDS and/or AML.
Proliferative index diagnosis
时间窗: 5 years
Ki-67 proliferative index (within populations and maturation) and its contribution to diagnosis. A lower Ki-67 proliferative index will lead to a more likely diagnose for MDS and/or AML.
Proliferative index prognosis
时间窗: 5 years
Ki-67 as prognostic parameter. A lower Ki-67 proliferative index will (hypothetically) lead to worse prognosis for MDS and AML in terms of: transfusion dependence (expressed in amount of transfusions in 2 months), chemotherapy response (expressed as total remission, normalization of blood values, possibly also normalization of cytogenetics in bone marrow cells), overall survival (expressed in months after diagnosis), Risk scores. Higher risk scores are correlated with worse prognosis.
次要结局
未报告次要终点
研究者
Stefan Mestrum
Principal Investigator
Maastricht University