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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-06743 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00007728 | Other Grant/Funding Number | Emory University Hospital/Winship Cancer Institute | |
| EU6255-24 | Other Identifier | Emory University Hospital/Winship Cancer Institute | |
| P30CA138292 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study explores the relationship between pre-treatment dietary patterns, fecal microbiome, and response to chemotherapy in patients with pancreatic ductal adenocarcinoma.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Patients complete a dietary survey and undergo fecal sample collection on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Response Rate | Major pathological response rate in surgical specimen of operable PDAC patients after neoadjuvant chemotherapy | Through study completion, an average of two years |
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Inclusion Criteria:
* Age ≥ 18 years with signed informed consent form
Exclusion Criteria:
* Patients with locally advanced and metastatic stage IV PDAC
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Patients with resectable or borderline resectable pancreatic ductal adenocarcinoma.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mihir M. Shah, MD, FACS, FSSO | Contact | 404-778-3307 | mihir.m.shah@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mihir M Shah | Emory University Hospital/Winship Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital/Winship Cancer Institute | Recruiting | Atlanta | Georgia | 30322 | United States |
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Shotgun Sequencing - Fecal Specimen
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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