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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEmory University

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 volunteers

Qualifiers

* 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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Non-Interventional Study

    Other intervention

    Non-interventional study

Treatment groups

87 Participants
are divided into 1 treatment group
Group A: Observational1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Through study completion, an average of two years

Secondary outcomes

1

Pathological Response Rate

Major pathological response rate in surgical specimen of operable PDAC patients after neoadjuvant chemotherapy

Time frame
Through study completion, an average of two years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

National Cancer Institute (NCI)

Collaborator