Determining the Link Between Dietary Patterns, Fecal Microbiome and Response to Neoadjuvant Chemotherapy in Pancreatic Ductal Adenocarcinoma Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Emory University
- Enrollment
- 87
- Locations
- 1
- Primary Endpoint
- Fecal Microbiome Alpha Diversity
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
This study explores the relationship between pre-treatment dietary patterns, fecal microbiome, and response to chemotherapy in patients with pancreatic ductal adenocarcinoma.
Detailed Description
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. Patients complete a dietary survey and undergo fecal sample collection on study.
Investigators
Mihir M. Shah, MD, FACS, FSSO
Principal Investigator
Emory University
Eligibility Criteria
Inclusion Criteria
- •\* Age ≥ 18 years with signed informed consent form
- •Patients must have a histological diagnosis of PDAC
- •Resectable or borderline resectable PDAC on imaging
Exclusion Criteria
- •\* 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
Outcomes
Primary Outcomes
Fecal Microbiome Alpha Diversity
Time Frame: 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.
Secondary Outcomes
- Pathological Response Rate(Through study completion, an average of two years)