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

NCT06595160 | Recruiting

• 4 other identifiers: STUDY00007728NCI-2024-06743EU6255-24P30CA138292
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  Through study completion, an average of two years

Secondary Outcomes (1)

• Pathological Response Rate

  Through study completion, an average of two years

Study Arms (1)

Observational

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

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with resectable or borderline resectable pancreatic ductal adenocarcinoma.

You may qualify if:

• \* Age ≥ 18 years with signed informed consent form
• Patients must have a histological diagnosis of PDAC
• Resectable or borderline resectable PDAC on imaging

You may not qualify if:

• \* 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

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Shotgun Sequencing - Fecal Specimen

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Mihir M Shah

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mihir M. Shah, MD, FACS, FSSO

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: August 5, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): August 7, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

US (1)