Evaluating Obesity-Mediated Mechanisms Of Pancreatic Carcinogenesis In Minority Populations

Study Overview

Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations

This study will evaluate obesity-mediated mechanisms of pancreatic carcinogenesis in minority populations.

This observational study will evaluate obesity-mediated mechanisms of pancreatic carcinogenesis in minority populations consisting of adult males or females, 18 years of age or older, who self-report as African American (AA) or Non-Hispanic White (NHW), and present to the gastrointestinal (GI) clinic, surgery, or endoscopy at a participating Florida Pancreas Collaborative (FPC) site or University of Mississippi Medical Center (UMMC) with a clinical suspicion or diagnosis of a pancreatic tumor. This study will also include patients who have been previously recruited as part of the FPC study. Our central hypothesis is that adipose tissue (AT) dysfunction contributes to malignant transformation, therapeutic resistance, and poor survival among obese AA pancreatic ductal adenocarcinoma (PDAC) cases and such dysfunction will be characterized by unique biology. The primary objective of this multi-institutional and multidisciplinary translational study is to identify a molecular and imaging profile unique to paired PDAC tumors and AT from AA and harness biological observations to predict therapeutic response and target novel obesity-mediated mechanisms of PDAC development and progression using in vitro, ex vivo, and in vivo techniques and new combinations of drug agents.

Pancreatic Cancer

OTHER: Blood Sample Collection
OTHER: Tissue Sample Collection
OTHER: Data Collection
OTHER: Medical Image Collection

MCC-21962
PA210192, W81XWH2211021 (OTHER_GRANT Identifier) (OTHER_GRANT: DOD)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-01-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-21
First Submitted that Met QC Criteria 2023-01-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-08-22
First Posted (ACTUAL) 2023-01-18	Results First Posted N/A	Last Verified 2025-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Retrospective Cohort Retrospective chart review and sample analysis of both pathologically confirmed Pancreatic Ductal Adenocarcinoma (PDAC) cases and non-Cancer control cases.
: Prospective Cohort Blood samples, tissue samples and data will be collected from all participants as applicable.	OTHER: Blood Sample Collection Participants will have 40 mL of blood drawn at baseline/pre-treatment. The study team will aim to have this blood collected at the time of standard of care blood draw if possible. OTHER: Tissue Sample Collection At the time of tissue biopsy or surgical resection (if applicable) pancreatic tumor tissue, fat, tissue from site of metastasis, and cyst fluid (if applicable) will be collected. OTHER: Data Collection Participants will complete a study questionnaire at baseline that includes medical history, lifestyle, and family history information. OTHER: Medical Image Collection Medical images that are obtained during routine care such as computed tomography (CT) scans, magnetic resonance imaging (MRIs) and ultrasounds will be reviewed by the study team throughout the participant's medical care.

Participant Group/Arm

Intervention/Treatment

: Retrospective Cohort

Retrospective chart review and sample analysis of both pathologically confirmed Pancreatic Ductal Adenocarcinoma (PDAC) cases and non-Cancer control cases.

: Prospective Cohort

Blood samples, tissue samples and data will be collected from all participants as applicable.

OTHER: Blood Sample Collection

Participants will have 40 mL of blood drawn at baseline/pre-treatment. The study team will aim to have this blood collected at the time of standard of care blood draw if possible.

OTHER: Tissue Sample Collection

At the time of tissue biopsy or surgical resection (if applicable) pancreatic tumor tissue, fat, tissue from site of metastasis, and cyst fluid (if applicable) will be collected.

OTHER: Data Collection

Participants will complete a study questionnaire at baseline that includes medical history, lifestyle, and family history information.

OTHER: Medical Image Collection

Medical images that are obtained during routine care such as computed tomography (CT) scans, magnetic resonance imaging (MRIs) and ultrasounds will be reviewed by the study team throughout the participant's medical care.

Primary Outcome Measures	Measure Description	Time Frame
Assess molecular and radiological landscape of traditional PDAC tumors in the context of Race/Ethnicity	Investigators will compare gene prevalence, type and expression of genetic mutations and radiomic features in African American participants vs Non-Hispanic White participants	at 36 months
Compare biological properties of Adipose Tissue dysfunction	Investigators will compare biological properties of Adipose Tissue dysfunction between African American vs Non-Hispanic White participants.	at 36 months
Examine the role of Adipose Tissue and PDAC tumor interactions in influencing tumor growth, metastasis, and therapeutic response	Investigators will compare the biological interactions of Adipose Tissue and PDAC tumor growth between African American vs. Non-Hispanic White participants to develop new and/or targeted drug combinations.	at 36 months

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Adults 18 years of age or older at time of signing informed consent
Patients who self-report as African American, Non-Hispanic White
Patients who present to the gastrointestinal (GI) clinic, surgery, or endoscopy at a participating Florida Pancreas Collaborative (FPC) site or the University of Mississippi Medical Center (UMMC) with a clinical suspicion or diagnosis of a pancreatic tumor.

Patient under 18 years of age
Has no suspicion or diagnosis of a pancreatic cancer or tumor
Self-reported race/ethnicity other than African American or Non-Hispanic White.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

United States Department of Defense

Investigators

PRINCIPAL_INVESTIGATOR: Jennifer Permuth, PhD, MS, Moffitt Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record