Determining the Link Between Dietary Patterns, Fecal Microbiome and Response to Neoadjuvant Chemotherapy
Purpose
This study explores the relationship between pre-treatment dietary patterns, fecal microbiome, and response to chemotherapy in patients with pancreatic ductal adenocarcinoma.
Conditions
- Borderline Resectable Pancreatic Ductal Adenocarcinoma
- Resectable Pancreatic Ductal Adenocarcinoma
- Stage I Pancreatic Cancer AJCC v8
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
| Arm | Description | Assigned Intervention |
|---|---|---|
| Observational | Patients complete a dietary survey and undergo fecal sample collection on study. |
|
Recruiting Locations
Atlanta 4180439, Georgia 4197000 30322
More Details
- NCT ID
- NCT06595160
- Status
- Recruiting
- Sponsor
- Emory University
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.