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临床试验/NCT03230240
NCT03230240Unknown不适用

Immunologic, Cellular, and Anti-microbial Profiling of Intraperitoneal Chemotherapy

MercyOne Des Moines Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

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

  1. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jan Franko, MD

Surgical Oncologist

MercyOne Des Moines Medical Center

研究点 (1)

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