Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations

May 21, 2026 updated by: H. Lee Moffitt Cancer Center and Research Institute
This study will evaluate obesity-mediated mechanisms of pancreatic carcinogenesis in minority populations.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

125

Contacts and Locations

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

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Active, not recruiting
        • Moffitt Cancer Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
        • Contact:
        • Principal Investigator:
          • Shannon Orr, MD

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients at a Florida Pancreas Collaborative site who identify as African American or Non-Hispanic White.

Description

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 Plan

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

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess molecular and radiological landscape of traditional PDAC tumors in the context of Race/Ethnicity
Time Frame: 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
at 36 months
Compare biological properties of Adipose Tissue dysfunction
Time Frame: at 36 months
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
Time Frame: 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.
at 36 months

Collaborators and Investigators

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

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Jennifer Permuth, PhD, MS, Moffitt Cancer Center
  • Principal Investigator: Mokenge Malafa, MD, Moffitt Cancer Center

Publications and helpful links

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

Helpful Links

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 Major Dates

Study Start (Actual)

February 22, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 6, 2023

First Submitted That Met QC Criteria

January 6, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-21962
  • PA210192, W81XWH2211021 (Other Grant/Funding Number: DOD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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