A Cohort Study of the Gastrointestinal Microbiome in Appendiceal Cancer With Peritoneal Spread
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Determine whether the intestinal microbiome of patients with appendiceal tumors with peritoneal carcinomatosis differs from that of a healthy, age-matched cohort
研究概览
简要总结
This study analyzes the gastrointestinal microbiome of appendiceal cancer patients with peritoneal spread scheduled to undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC). Participants will provide fecal samples pre- and post-operatively.
详细描述
Analysis of the human microbiome is an attempt to define how changes in the human microbiome are associated with health or disease.
Eligible participants scheduled to undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) for appendiceal cancer will provide fecal samples pre- and post-operatively. Investigators will analyze potential changes in the gastrointestinal microbiome and make comparisons to an age-matched healthy sample.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Diagnosis of appendiceal cancer with peritoneal spread
- •Candidate for cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC)
- •≥18 and ≤ 80 years of age
- •Eastern Cooperative Oncology Group performance status score of ≤2/Karnofsky performance status (KPS) ≥70%
- •Signed Institutional Review Board approved informed consent
排除标准
- •<18 years of age
- •Pregnant women
- •Concurrent severe medical problems unrelated to malignancy
结局指标
主要结局
Determine whether the intestinal microbiome of patients with appendiceal tumors with peritoneal carcinomatosis differs from that of a healthy, age-matched cohort
时间窗: 36 months
Appendiceal cohort to healthy age-matched cohort
次要结局
- Compare the gut microbiome of appendiceal tumors by histopathology(36 months)
研究者
Armando Sardi
Chief Surgical Oncology at Mercy
Mercy Medical Center