Immunologic, Cellular, and Anti-microbial Profiling of Intraperitoneal Chemotherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- In vitro growth of Staph Aureus and Escherichia coli measured in millimeters of colony forming unit on Agar plate
研究概览
简要总结
To ascertain immunologic profile of peritoneal cavity and its relationship to immediate postsurgical outcome (morbidity or the treatment) and long-term outcome (time to recurrence and survival).
详细描述
- BACKGROUND:
Tumor-host interaction includes inactivation of immunologic recognition of malignant cells by a mechanism yet not fully understood. Aneuplodity studies on cells from different metastatic sites demonstrate increased heterogeneity depending on metastatic site (Kimball 1997). This suggests that phenotypically different cell populations are responsible for different metastases and may demonstrate different sensitivity/resistance to treatment. Kitayama (2015) studied ratio of lymphocytes to epithelial cell in peritoneal cavity, but used this ratio only as marker of tumor burden and did not relate it to perioperative outcome.
Investigators have clinically observed a different behavior of peritoneal metastases as compared to those located in other body sites (Franko 2012, Klaver 2012, Franko 2016). It is hypothesized that tumor-host interaction and host-treatment response are related to treatment-related morbidity, early vs. delayed recurrence, and overall survival.
There is a limited literature and research examining the immunologic profile of intraperitoneal chemotherapy and its relationship to morbidity and future metastatic sites. Therefore, further knowledge of the biology of different peritoneal surface metastatic disease is necessary. This, with additional research, may lead to specific therapies. 2. OBJECTIVES:
To ascertain immunologic profile of peritoneal cavity and its relationship to immediate postsurgical outcome (morbidity or the treatment) and long-term outcome (time to recurrence and survival). 3. STUDY POPULATION:
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 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •absent consent
研究组 & 干预措施
HIPEC
Patients with carcinomatosis or other peritoneal surface malignancy
干预措施: HIPEC (Drug)
结局指标
主要结局
In vitro growth of Staph Aureus and Escherichia coli measured in millimeters of colony forming unit on Agar plate
时间窗: 1 year after operation
次要结局
未报告次要终点
研究者
Jan Franko, MD
Surgical Oncologist
MercyOne Des Moines Medical Center
