Myeloid-derived Suppressor Cells in Colorectal Cancer: Influence on Postoperative Complications and Neoadjuvant Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Level of MDSC in patients with postoperative complications
研究概览
简要总结
The aim of the study is to evaluate whether the preoperative level of myeloid-derived suppressor cells is associated with postoperative complications classified by Clavien-Dindo categories. Levels of all MDSC, polymorphonuclear MDSC (PMNMDSC), monocytic MDSC (MMDSC), early-stage MDSC (EMDSC) and monocytic to polymorphonuclear MDSC ratio (M/PMN MDCS) were established and compared in patients with postoperative complications, severe postoperative complications (>= IIIA according to Clavien-Dindo) and severe septic complications.
详细描述
Levels of all MDSC, polymorphonuclear MDSC (PMNMDSC), monocytic MDSC (MMDSC), early-stage MDSC (EMDSC) and monocytic to polymorphonuclear MDSC ratio (M/PMN MDCS) were established and compared in patients with and without postoperative complications. Then subgroup analysis was performed to compare levels of MDSC in patients with severe postoperative complications (>= IIIA according to Clavien-Dindo) and those without severe complications. Another subgroup analysis will be performed for patients with severe septic complications that are defined as severe complications with accompanying infection. Levels of MDSC will be compared by means of U Mann Whitney test as their distribution is not normal. After above mentioned analyses it will be possible to evaluate the role of MDSC in patients with colorectal cancer in terms of postoperative complications. Additional analyse will be performed to compare levels of MDSC in patients who underwent neoadjuvant treatment (radiotherapy or chemoradiotherapy).
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
- •colorectal cancer confirmed by histological examination of biopsy specimen
- •elective operation
- •signed informed consent
排除标准
- •Age < 18
- •Pregnancy or lactation
- •Emergency operation
- •General condition that precludes understanding and signing of the informed consent form
结局指标
主要结局
Level of MDSC in patients with postoperative complications
时间窗: 30 days
Level of all MDSC, polymorphonuclear MDSC (PNMMDSC), monocytic MDSC ( MMDSC), early-stage MDSC (EMDSC) and monocytic to polymorphonuclear MDSC ratio (M/PMNMDSC) in patients with postoperative complications
次要结局
- Level of MDSC in patients with severe septic postoperative complications(30 days)
- Level of MDSC in patients after neoadjuvant therapy(1 day before surgery)
- Level of MDSC in patients with left and right sided tumours(1 day)
- Level of MDSC in patients with severe postoperative complications(30 days)
- Level of MDSC in patients with T2-T4 tumours after neoadjuvant treatment(1 day before surgery)
- Level of MDSC measured in the specimen(1 day)
研究者
Radoslaw Pach, MD, Ph D
Principal Investigator
Jagiellonian University