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

Emory University

Status

Enrolling

Conditions

Resectable Pancreatic Ductal Adenocarcinoma

Stage I Pancreatic Cancer AJCC v8

Borderline Resectable Pancreatic Ductal Adenocarcinoma

Treatments

Other: Non-Interventional Study

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT06595160

P30CA138292 (U.S. NIH Grant/Contract)

STUDY00007728

NCI-2024-06743 (Registry Identifier)

EU6255-24 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

87 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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