Recruiting

Plant-based Diet

Sponsor:

Emory University

Code:

NCT06595160

Conditions

Borderline Resectable Pancreatic Ductal Adenocarcinoma

Resectable Pancreatic Ductal Adenocarcinoma

Stage I Pancreatic Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

Brief summary:

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

Study ID

NCT06595160

Start date

Aug 5, 2024

Status verified date

Jul, 2025

Completion date

Aug 7, 2027

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

87 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

Patients complete a dietary survey and undergo fecal sample collection on study.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Fecal Microbiome Alpha Diversity [ Time Frame: Through study completion, an average of two years ]

Central Contacts and Locations

Central contacts

Mihir M. Shah, MD, FACS, FSSO

404-778-3307mihir.m.shah@emory.edu

Locations

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Mihir M. Shah

404-778-3307mihir.m.shah@emory.edu

Principal Investigator:

Mihir M. Shah

More Information

Sponsor

Emory University

Last update posted

Aug 1, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2025-08-01.