Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05687188

Enrollment

125

Registered

2023-01-18

Start date

2023-02-22

Completion date

2026-12-01

Last updated

2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

pancreas, biomarkers, health disparities

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.

Interventions

OTHERBlood 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.

OTHERTissue 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.

OTHERData Collection

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

OTHERMedical 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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
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.
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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJennifer Permuth, PhD, MS

Moffitt Cancer Center

PRINCIPAL_INVESTIGATORMokenge Malafa, MD