Actively Recruiting
Determining the Link Between Dietary Patterns, Fecal Microbiome and Response to Neoadjuvant Chemotherapy in Pancreatic Ductal Adenocarcinoma Patients
Led by Emory University · Updated on 2025-08-01
87
Participants Needed
1
Research Sites
66 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to explore how pre-treatment dietary habits and the variety of bacteria in fecal samples relate to how patients with pancreatic ductal adenocarcinoma respond to chemotherapy before surgery. The study focuses on patients with operable pancreatic cancer who are undergoing neoadjuvant chemotherapy and seeks to understand important links between diet, gut microbiome diversity, and treatment outcomes. Participants provide information through a dietary survey and give fecal samples for analysis. This observational study does not involve any treatment interventions but collects data to evaluate the associations between diet quality, microbiome diversity, and pathological response to chemotherapy. During the study, researchers assess the variety of bacteria in fecal samples and measure the patients' dietary quality using the HEI-2015 score. They also track the major pathological response to chemotherapy over an average period of two years. The study is designed to better understand these relationships without altering patient care, and participants contribute by completing surveys and providing samples.
CONDITIONS
Brief Title
Determining the Link Between Dietary Patterns, Fecal Microbiome and Response to Neoadjuvant Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with signed informed consent
- Histological diagnosis of pancreatic ductal adenocarcinoma (PDAC)
- Resectable or borderline resectable PDAC confirmed by imaging
You will not qualify if you...
- Locally advanced or metastatic stage IV pancreatic ductal adenocarcinoma
- Previous receipt or completion of neoadjuvant chemotherapy for PDAC
- Active malignancy currently receiving systemic therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks
Participants complete a dietary survey and provide fecal samples for microbiome analysis before any treatment.
1 to 2 visits depending on sample collection and dietary survey completion
Duration - Up to 2 years
Participants are observed over time to assess fecal microbiome diversity and response to neoadjuvant chemotherapy.
Periodic visits as needed during study completion
Trial Site Locations
Total: 1 location
1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
M
Mihir M. Shah, MD, FACS, FSSO
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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