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Recruiting NCT06595160

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

— Observational Borderline Resectable Pancreatic Ductal Adenocarcinoma Resectable Pancreatic Ductal Adenocarcinoma Stage I Pancreatic Cancer AJCC v8

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-Interventional Study.
Who it may be relevant to
Registry conditions: Borderline Resectable Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Ductal Adenocarcinoma, Stage I Pancreatic Cancer AJCC v8. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other Non-Interventional Study
    Non-interventional study

Primary outcome measures

  • Fecal Microbiome Alpha Diversity [Time frame: Through study completion, an average of two years]
Secondary outcome measures (1)
  • Pathological Response Rate [Time frame: Through study completion, an average of two years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Emory University Hospital/Winship Cancer Institute — Atlanta

Identifiers

NCT: NCT06595160 · STUDY00007728 · NCI-2024-06743 · STUDY00007728 · EU6255-24 · P30CA138292

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗