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NCT06595160Recruiting

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

Emory University

Start Date

8/5/2024

Completion Date

8/7/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

OTHER

Non-Interventional Study

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Conditions

Borderline Resectable Pancreatic Ductal AdenocarcinomaResectable Pancreatic Ductal AdenocarcinomaStage I Pancreatic Cancer AJCC v8

Locations

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

United States