Borderline Resectable Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Ductal Adenocarcinoma, Stage I Pancreatic Cancer AJCC v8
Conditions
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.
Interventions
OTHERNon-Interventional Study
Non-interventional study
Sponsors
National Cancer Institute (NCI)
Emory University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Response Rate | Through study completion, an average of two years | Major pathological response rate in surgical specimen of operable PDAC patients after neoadjuvant chemotherapy |
Countries
United States
Contacts
Primary ContactMihir M. Shah, MD, FACS, FSSO
Outcome results
None listed