NCT06595160 · Emory University
Determining the Link Between Dietary Patterns, Fecal Microbiome and Response to Neoadjuvant Chemotherapy
What this study is about
This study explores the relationship between pre-treatment dietary patterns, fecal microbiome, and response to chemotherapy in patients with pancreatic ductal adenocarcinoma.
View original scientific description
This study explores the relationship between pre-treatment dietary patterns, fecal microbiome, and response to chemotherapy in patients with pancreatic ductal adenocarcinoma.
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Atlanta, Georgia
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 1, 2025 · Source of record for eligibility and locations