Determining The Link Between Dietary Patterns, Fecal Microbiome And Response To Neoadjuvant Chemotherapy

Study Overview

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

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.

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

OTHER: Non-Interventional Study

STUDY00007728
NCI-2024-06743 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trial Reporting Program))
STUDY00007728 (OTHER_GRANT Identifier) (OTHER_GRANT: Emory University Hospital/Winship Cancer Institute)
EU6255-24 (OTHER Identifier) (OTHER: Emory University Hospital/Winship Cancer Institute)
P30CA138292 (U.S. NIH Grant/Contract)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-09-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-07-30
First Submitted that Met QC Criteria 2024-09-11	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-08-01
First Posted (ACTUAL) 2024-09-19	Results First Posted N/A	Last Verified 2025-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Observational Patients complete a dietary survey and undergo fecal sample collection on study.	OTHER: Non-Interventional Study Non-interventional study

Participant Group/Arm

Intervention/Treatment

: Observational

Patients complete a dietary survey and undergo fecal sample collection on study.

OTHER: Non-Interventional Study

Non-interventional study

Primary Outcome Measures	Measure Description	Time Frame
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.	Through study completion, an average of two years

Secondary Outcome Measures	Measure Description	Time Frame
Pathological Response Rate	Major pathological response rate in surgical specimen of operable PDAC patients after neoadjuvant chemotherapy	Through study completion, an average of two years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Mihir M. Shah, MD, FACS, FSSO

Phone Number: 404-778-3307

Email: mihir.m.shah@emory.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Age ≥ 18 years with signed informed consent form

Patients must have a histological diagnosis of PDAC
Resectable or borderline resectable PDAC on imaging

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: Mihir M Shah, Emory University Hospital/Winship Cancer Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record