Radioinduced Modifications of Lymphocyte Subpopulations Involved in Resistence and Escape Mechanisms to Radiation Therapy of Localized Prostate Cancer.
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- to quantify the variation in lymphocyte subpopulations T, NK, B, Breg and Treg,
研究概览
简要总结
Radiotherapy has an important role in the treatment of prostate cancer both as curative treatment and postoperative or salvage ones. Several studies demonstrated a significant reduction of lymphocytes during RT but there are only a few studies monitoring these cells in the treatment of prostate cancer. This study will enroll 50 patients with hystologically proven prostate cancer who will undergo to radiotherapy according to Institutional protocols.
This study aims to evaluate the effect of RT on immuno-regulatory B, NK, T, B and T lymphocyte subpopulations (Breg and Treg) and plasma cells, quantitative / qualitative changes,their correlations with the clinical course of the disease and acute and late toxicity. In parallel, using multicolor panels (12 colors) we will evaluate the expression of inhibitory checkpoints and TGFβ signaling.
The final objective is to identify new therapeutic targets to be combined with RT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically documented prostatic cancer
- •Indication to perform radiotherapy treatment
- •Age over 18 years
- •Informed consent
排除标准
- •Hematological diseases
- •Autoimmune diseases
- •Previous neoplasias
- •Prior chemotherapy or other therapies that may have violated the hematopoietic organs
- •Patient's refusal to undergo periodic blood samples
结局指标
主要结局
to quantify the variation in lymphocyte subpopulations T, NK, B, Breg and Treg,
时间窗: 12 months
quantitative variation
次要结局
未报告次要终点
研究者
Giuseppe Sanguineti
Radioinduced Modifications of Lymphocyte Subpopulations Involved in Resistence and Escape Mechanisms to Radiation Therapy of Localized Prostate Cancer.
Regina Elena Cancer Institute