Clinical trial NCT05687188: Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations
Official title: Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cancer
Keywords: pancreas
biomarkers
health disparities
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2023-01-18
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at a Florida Pancreas Collaborative site who identify as African American or Non-Hispanic White.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assess molecular and radiological landscape of traditional PDAC tumors in the context of Race/Ethnicity
timeFrame: at 36 months
measure: Compare biological properties of Adipose Tissue dysfunction
timeFrame: at 36 months
measure: Examine the role of Adipose Tissue and PDAC tumor interactions in influencing tumor growth, metastasis, and therapeutic response
timeFrame: at 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: Moffitt Cancer Center
name: Jennifer Permuth, PhD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Moffitt Cancer Center
name: Mokenge Malafa, MD
role: PRINCIPAL_INVESTIGATOR
References: