About this trial
This study explores the relationship between pre-treatment dietary patterns, fecal microbiome, and response to chemotherapy in patients with pancreatic ductal adenocarcinoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
* Age ≥ 18 years with signed informed consent form
Patients must have a histological diagnosis of PDAC
Resectable or borderline resectable PDAC on imaging
Disqualifiers
* 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
Trial population
Patients with resectable or borderline resectable pancreatic ductal adenocarcinoma.
Trial design
Case-only
Prospective
Treatments tested in this trial
Non-Interventional Study
Other interventionNon-interventional study
Treatment groups
Trial outcomes
Primary outcomes
Fecal Microbiome Alpha Diversity
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 outcomes
Pathological Response Rate
Major pathological response rate in surgical specimen of operable PDAC patients after neoadjuvant chemotherapy
Sponsors and contacts
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Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator