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

NCT06595160 · Emory University

Recruiting

In plain English

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Official title

Determining the Link Between Dietary Patterns, Fecal Microbiome and Response to Neoadjuvant Chemotherapy in Pancreatic Ductal Adenocarcinoma Patients

About this study

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.

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

Study design

Enrollment target: 87 participants

Age groups: adult, older_adult

Timeline

Starts: 2024-08-05

Estimated completion: 2027-08-07

Last updated: 2025-08-01

Interventions

Other: Non-Interventional Study

Primary outcomes

• Fecal Microbiome Alpha Diversity (Through study completion, an average of two years)

Sponsor

Emory University · other

With: National Cancer Institute (NCI)

Contacts & investigators

ContactMihir M. Shah, MD, FACS, FSSO · contact · mihir.m.shah@emory.edu · 404-778-3307

InvestigatorMihir M Shah · principal_investigator, Emory University Hospital/Winship Cancer Institute

All locations (1)

Emory University Hospital/Winship Cancer InstituteRecruiting

Atlanta, Georgia, United States

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