Determining the Link Between Dietary Patterns, Fecal Microbiome and Response to Neoadjuvant Chemotherapy
NCT ID: NCT06595160
Last Updated: 2025-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
87 participants
OBSERVATIONAL
2024-08-05
2027-08-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Observational
Patients complete a dietary survey and undergo fecal sample collection on study.
Non-Interventional Study
Non-interventional study
Interventions
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Non-Interventional Study
Non-interventional study
Eligibility Criteria
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Inclusion Criteria
* Patients must have a histological diagnosis of PDAC
* Resectable or borderline resectable PDAC on imaging
Exclusion Criteria
* Patients who have already received or completed neoadjuvant chemotherapy for PDAC
* Patients with active malignancy receiving systemic therapy
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Emory University
OTHER
Responsible Party
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Mihir M. Shah, MD, FACS, FSSO
Principal Investigator
Principal Investigators
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Mihir M Shah
Role: PRINCIPAL_INVESTIGATOR
Emory University Hospital/Winship Cancer Institute
Locations
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Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2024-06743
Identifier Type: REGISTRY
Identifier Source: secondary_id
STUDY00007728
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
EU6255-24
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00007728
Identifier Type: -
Identifier Source: org_study_id
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