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Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Observational Patients complete a dietary survey and undergo fecal sample collection on study.
  • Other: Non-Interventional Study
    Non-interventional study

Recruiting Locations

Emory University Hospital/Winship Cancer Institute
Atlanta 4180439, Georgia 4197000 30322
Contact:
Mihir M. Shah
404-778-3307
mihir.m.shah@emory.edu

More Details

NCT ID
NCT06595160
Status
Recruiting
Sponsor
Emory University

Study Contact

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

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.

Notice

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Vanderbilt University Medical Center