Prognostic Value Of Lymphocyte Count and Lymphocyte/ Monocyte Ratio in Patients With Hodgkin's Lymphoma
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
This study is to assess the utility of using Absolute Lymphocyte count, Lymphocyte/Monocyte Ratio and International Prognostic Scote at diagnosis in Hodgkin's Lymphoma as a prognostic predictor of therapeutic response, overall survival and progression free survival
详细描述
Hodgkin's Lymphoma has a high cure rate even if patients do not complete their treatment, this proposes that some patients may experience overtreatment and that would have negative effects (such as cardiac toxicity, sterility, secondary malignancies...) which makes it imperative to search for prognostic predictor suitable for all stages of disease, knowing that the International Prognostic Score "IPS" is restricted to advanced stages of the disease.
Absolute Lymphocyte count reflects the immune status of the individuals. It has been shown that an individual's immune status controls the extent of his response treatment, overall survival and his progression free survival because of the role that Lymphocytes play in suppressing and eliminating tumor cells.
Tumor-Associated Macrophages "TAMs" have been shown to play a role in tumor growth and development. Also, it has been shown that an increase in peripheral Monocyte count is associated with an increase in TAMs, so that the Monocyte count may constitute an important prognostic predictor.
Combining the Lymphocyte count and the Monocyte count into one index may be better for estimating the prognosis.
The aim of this study is to determine the prognostic significance of Absolute Lymphocyte count "ALC", Lymphocyte/Monocyte Ratio "LMR" and International Prognostic Score "IPS" at the cut-off points: 1500 cells per microliter for ALC, 2.9 for LMR and Score=3 for IPS.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed patients with Hodgkin's Lymphoma who have not yet received treatment
- •Ages over 16 years old
- •Signed informed consent before registration in study
排除标准
- •Patients who have already received treatment
- •Patients with a previous history of malignancy
- •Patients with autoimmune diseases
- •Patients with primary immunodeficiency
- •AIDS patients
- •Patients with acute or chronic infections
- •Patients treated with drugs that affect the result of the analysis (Corticosteroids, Immunosuppressants, Li)
结局指标
主要结局
overall survival
时间窗: 18 months
The occurrence of death after acceptance to study
progression free survival
时间窗: 18 months
The occurrence of relapse after acceptance to study
Therapeutic response
时间窗: 6 months
Achieve complete remission after completing the prescribed treatment plan
次要结局
未报告次要终点