Determining the Link Between Dietary Patterns, Fecal Microbiome and Response to Neoadjuvant Chemotherapy

Emory University87 enrolled

Overview

This study explores the relationship between pre-treatment dietary patterns, fecal microbiome, and response to chemotherapy in patients with pancreatic ductal adenocarcinoma.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Borderline Resectable Pancreatic Ductal Adenocarcinoma Resectable Pancreatic Ductal Adenocarcinoma Stage I Pancreatic Cancer AJCC v8

Interventions

Non-Interventional StudyOTHER

Non-interventional study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

RECRUITING

Outcomes

Primary Outcomes

Fecal Microbiome Alpha Diversity

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.

Time frame: Through study completion, an average of two years

Secondary Outcomes

Pathological Response Rate

Major pathological response rate in surgical specimen of operable PDAC patients after neoadjuvant chemotherapy

Time frame: Through study completion, an average of two years

Central Contacts

Mihir M. Shah, MD, FACS, FSSO

CONTACT

404-778-3307 mihir.m.shah@emory.edu

Data from ClinicalTrials.gov

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