Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations

H. Lee Moffitt Cancer Center and Research Institute

Status: Enrolling

Conditions: Pancreatic Cancer

Treatments: Other: Data Collection; Other: Medical Image Collection; Other: Tissue Sample Collection; Other: Blood Sample Collection

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05687188

MCC-21962

PA210192, W81XWH2211021 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

125 participants in 2 patient groups

Retrospective Cohort

Description:

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

Prospective Cohort

Description:

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

Treatment:

Other: Blood Sample Collection

Other: Medical Image Collection

Other: Tissue Sample Collection

Other: Data Collection