COLON MD: Colon Cancer Longitudinal Study of the Microbial Metabolites and Dietary Factors That Influence Response to Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Microbiome-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer
研究概览
简要总结
The goal of this proposal is to identify how the composition of the gut microbiome and diet interact to impact chemotherapy-induced diarrhea incidence and severity.
详细描述
In this longitudinal observational study patients will supply samples of their gut microbiome prior to scheduled colonoscopy or surgery along with dietary intake and blood samples; the relative abundance of microbes from those samples along with dietary data will be used to predict the presence or absence and severity of chemotherapy-induced diarrhea. Microbiome and diet based predictions from blinded samples will be combined to map the diet-microbiome changes during treatment to the changes in immune markers and risk of chemotherapy-induced diarrhea.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colon cancer diagnosis
- •Age >18 and < or equal to
- •Ability to perform informed consent
- •FOLFOX treatment expected
排除标准
- •Not Pregnant
- •Does not have Lynch syndrome or FAP diagnosis.
- •Inability to perform inform consent
- •inability to comply with follow up program
- •history of prior colon cancer diagnosis
- •previous treatment with antibiotics in the last month.
- •previous bowel resection.
研究组 & 干预措施
Observational
All patients going on study will be put in the observational grouping for blood and tissue collection with option for stool collection.
结局指标
主要结局
Microbiome-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer
时间窗: 3 years
Microbiome analysis from at least 112 blinded samples will be conducted from fecal samples to determine sensitivity, specificity and accuracy (reported as percentage) of a microbiome-based predictor of chemotherapy-induced diarrhea in colon cancer.
次要结局
- Dietary-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer(3 years)