Determining the Link Between Dietary Patterns, Fecal Microbiome and Response to Neoadjuvant Chemotherapy in Pancreatic Ductal Adenocarcinoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Fecal Microbiome Alpha Diversity
研究概览
简要总结
This study explores the relationship between pre-treatment dietary patterns, fecal microbiome, and response to chemotherapy in patients with pancreatic ductal adenocarcinoma.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the association between pre-treatment diversity of the fecal microbiome and major pathological response to neoadjuvant chemotherapy in operable pancreatic ductal adenocarcinoma patients.
II. Evaluate the association between pre-treatment HEI-2015 dietary score and major pathological response to neoadjuvant chemotherapy in pancreatic ductal adenocarcinoma patients.
III. Evaluate the association between pre-treatment HEI-2015 dietary score and diversity of the fecal microbiome in pancreatic ductal adenocarcinoma patients.
OUTLINE: This is an observational study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* Age ≥ 18 years with signed informed consent form
- •Patients must have a histological diagnosis of PDAC
- •Resectable or borderline resectable PDAC on imaging
排除标准
- •* Patients with locally advanced and metastatic stage IV PDAC
- •Patients who have already received or completed neoadjuvant chemotherapy for PDAC
- •Patients with active malignancy receiving systemic therapy
结局指标
主要结局
Fecal Microbiome Alpha Diversity
时间窗: Through study completion, an average of two years
Continuous variables will be presented as median with interquartile range and categorical variables will be presented as frequencies. Univariate logistic regression will be used to compare alpha diversity (mean inverse Simpson index) and relative abundance of operational taxonomic units up to species level in PDAC patients with and without major pathological response to neoadjuvant chemotherapy. Multivariable logistic regression analyses will be performed to identify significant factors associated with major pathological response after adjusting for age, gender, stage at presentation, and type of neoadjuvant chemotherapy and other factors based on univariate analyses or clinical significance.
次要结局
- Pathological Response Rate(Through study completion, an average of two years)
研究者
Mihir M. Shah, MD, FACS, FSSO
Principal Investigator
Emory University