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NCT06595160 | RECRUITING | Borderline Resectable Pancreatic Ductal Adenocarcinoma

Association of Plant-based Diet and Gut Microbiome Signature with Response to Neoadjuvant Therapy in Pancreatic Ductal Adenocarcinoma
Sponsor:

Emory University

Information provided by (Responsible Party):

Mih M. Shah, MD, FSO, FSSO

Brief Summary:

This study explores the relationship between pre-treatment dietary patterns, fecal microbiome, and response to chemotherapy in patients with pancreatic ductal adenocarcinoma.

Condition or disease

Borderline Resectable Pancreatic Ductal Adenocarcinoma

Resectable Pancreatic Ductal Adenocarcinoma

Stage I Pancreatic Cancer AJCC V8

Intervention/treatment

Non-Interventional Study

Detailed Description:

PRIMARY OBJECTIVES: I. Evaluate the association between pre-treatment diversity of the fecal microbiome and major pathological response to neoadjuvant chemotherapy in operable pancreatic ductal adenocarcinoma patients. II. Evaluate the association between pre-treatment HEI-2015 dietary score and major pathological response to neoadjuvant chemotherapy in pancreatic ductal adenocarcinoma patients. III. Evaluate the association between pre-treatment HEI-2015 dietary score and diversity of the fecal microbiome in pancreatic ductal adenocarcinoma patients. OUTLINE: This is an observational study. Patients complete a dietary survey and undergo fecal sample collection on study.

Study Type : OBSERVATIONAL
Estimated Enrollment : 87 participants
Official Title : Exploring the Relationship Between Dietary Patterns, Fecal Microbiome and Response to Neoadjuvant Chemotherapy in Pancreatic Ductal Adenocarcinoma Patients
Actual Study Start Date : 2024-08-05
Estimated Primary Completion Date : 2026-04-30
Estimated Study Completion Date : 2027-08-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Association of Plant-based Diet and Gut Microbiome Signature with Response to Neoadjuvant Therapy in Pancreatic Ductal Adenocarcinoma

Location Details

NCT06595160

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Locations

RECRUITING

United States, Georgia

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States, 30322