Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations

Recruiting

• Conditions: Pancreatic Cancer
• Interventions: Other: Blood Sample Collection; Other: Tissue Sample Collection; Other: Data Collection; Other: Medical Image Collection

• Registration Number: NCT05687188
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-06
• Study First Posted: 2023-01-18
• Study Start: 2023-02-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective Cohort	Medical Image Collection	Blood samples, tissue samples and data will be collected from all participants as applicable.
Prospective Cohort	Tissue Sample Collection	Blood samples, tissue samples and data will be collected from all participants as applicable.
Prospective Cohort	Blood Sample Collection	Blood samples, tissue samples and data will be collected from all participants as applicable.
Prospective Cohort	Data Collection	Blood samples, tissue samples and data will be collected from all participants as applicable.

Primary Outcome Measures

Name	Time	Method
Compare biological properties of Adipose Tissue dysfunction	at 36 months	Investigators will compare biological properties of Adipose Tissue dysfunction between African American vs Non-Hispanic White participants.
Assess molecular and radiological landscape of traditional PDAC tumors in the context of Race/Ethnicity	at 36 months	Investigators will compare gene prevalence, type and expression of genetic mutations and radiomic features in African American participants vs Non-Hispanic White participants
Examine the role of Adipose Tissue and PDAC tumor interactions in influencing tumor growth, metastasis, and therapeutic response	at 36 months	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.

Trial Locations

Locations (2)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States