Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-22 @ 5:42 PM
Study NCT ID:
NCT06595160
Status:
RECRUITING
Last Update Posted:
2025-08-01
First Post:
2024-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determining the Link Between Dietary Patterns, Fecal Microbiome and Response to Neoadjuvant Chemotherapy
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
Determining the Link Between Dietary Patterns, Fecal Microbiome and Response to Neoadjuvant Chemotherapy in Pancreatic Ductal Adenocarcinoma Patients
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study explores the relationship between pre-treatment dietary patterns, fecal microbiome, and response to chemotherapy in patients with pancreatic ductal adenocarcinoma.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2024-06743 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| STUDY00007728 | OTHER_GRANT | Emory University Hospital/Winship Cancer Institute | View | |
| EU6255-24 | OTHER | Emory University Hospital/Winship Cancer Institute | View | |
| P30CA138292 | NIH | None | https://reporter.nih.gov/quic… | View |