Longitudinal Study of the Effect of Cytoreductive Surgery and HIPEC in Patients With Peritoneal Carcinomatoses
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Disease free survival
研究概览
简要总结
Longitudinal Study of the Effect of Cytoreductive Surgery and HIPEC in Patients With Peritoneal Carcinomatoses
详细描述
Cross-sectional and longitudinal analysis of cellular immune responses in the context of disease outcome.
Cross-sectional and longitudinal analysis of the microbiome in the context of disease outcome.
Analysis of renal function with respect of different HIPEC regimens
Identification of clinical surrogate parameters for outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suspicious peritoneal carcinomatosis
排除标准
- •<18 years
结局指标
主要结局
Disease free survival
时间窗: Through study completion, an average of 3 years
Prospective analysis of disease free after CRS/HIPEC for peritoneal carcinomatosis
Overall survival
时间窗: Through study completion, an average of 3 years
Prospective analysis of overall survival after CRS/HIPEC for peritoneal carcinomatosis
次要结局
- Renal function (serum creatinine (mg/dl))(Before as well as during the first 7 days postoperative)
- Renal function (urine output (ml/24h))(Before as well as during the first 7 days postoperative)
- Microbiome (Bacterial 16S ribosomal RNA gene sequences will be amplified, sequenced, and analyzed in comparison to publicly available data obtained from healthy volunteers)(Before as well as at postoperative day 2 and 7)
- Renal function (urea (mg/dl))(Before as well as during the first 7 days postoperative)
- Quality of life (Questionnaire-WHOQOL-BREF)(Before surgery and through study completion, an average of 3 years)
- Cellular immune response (Frequency of NK cell subpopulations within lymphocyte populations measured by flow cytometry)(Before as well as at postoperative day 2 and 7)
研究者
Hans J Schlitt, Prof. MD
Head of Surgery
University of Regensburg