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NCT Number: NCT06595160

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.

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Key information

Conditions

Borderline Resectable Pancreatic Ductal Adenocarcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Resectable Pancreatic Ductal Adenocarcinoma Stage I Pancreatic Cancer AJCC v8

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location status: Recruiting

Location contact

Mihir M. Shah

CONTACT

[email protected]

404-778-3307

Mihir M. Shah

PRINCIPAL_INVESTIGATOR

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

  1. Fecal Microbiome Alpha Diversity

    Time frame: Through study completion, an average of two years

    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.

Secondary outcomes

  1. Pathological Response Rate

    Time frame: Through study completion, an average of two years

    Major pathological response rate in surgical specimen of operable PDAC patients after neoadjuvant chemotherapy

Study contacts

Contact information is provided by the study sponsor or research team.

Mihir M. Shah, MD, FACS, FSSO

CONTACT

[email protected]

404-778-3307

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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