Association of Plant-based Diet and Gut Microbiome Signature with Response to Neoadjuvant Therapy in Pancreatic Ductal Adenocarcinoma

Recruiting

• Conditions: Borderline Resectable Pancreatic Ductal Adenocarcinoma; Resectable Pancreatic Ductal Adenocarcinoma; Stage I Pancreatic Cancer AJCC V8
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06595160
• Lead Sponsor: Emory University

Brief 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.

Study Timeline

• Study Start: 2024-08-05
• Status Verified: 2024-09
• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-11
• Last Update Submitted: 2024-09-11
• Study First Posted: 2024-09-13
• Last Update Posted: 2024-09-13
• Primary Completion: 2026-04-30
• Study Completion: 2027-08-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 87

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional Study	Patients complete a dietary survey and undergo fecal sample collection on study.

Primary Outcome Measures

Name	Time	Method
Fecal microbiome alpha diversity	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.

Trial Locations

Locations (1)

Emory University Hospital/Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States