Clinical Trial 21962

• Overview

  Study Title:

  Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations

  Summary:

  This research study will enroll people 18 years of age and older who have, or are suspected to have, a pancreatic tumor or cancer and are being seen at a participating Florida Pancreas Collaborative site or the University of Mississippi Medical Center (UMMC). Investigators will study blood, tissues, other body fluids, medical images, clinical records and survey information to build a large database of information and samples for use in ongoing and future research studies, including the development of noninvasive diagnostic approaches that could be used as decision-making tools to effectively personalize clinical care.

  Objective:

  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. Primary Objective 1: To evaluate the molecular and radiologic landscape of PDAC tumors from AA and NHW. Secondary Objectives: - Compare the prevalence, type, and dosage of mutations and copy number variants (CNV). - Examine differences between groups in classical/cholesterogenic versus basal-like subtype gene expression. - Evaluate radiomic and delta computed tomography (CT) features of PDAC tumors between groups. Primary Objective 2: To compare biological properties of AT dysfunction between AA and NHW PDAC cases and non-cancer controls. Secondary Objectives: - Examine the regional quantity/distribution of visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and intrapancreatic fat (IPF) using pre-treatment CT scans. - Evaluate structural, functional, and molecular aspects of paired VAT and SAT from AA and NHW cases. - Assess morphological and molecular/functional profile of adipocytes in racial groups via the following: i. Assess adipocyte size and number; ii. Measure expression of markers of senescence, necrosis, inflammation, and lipolysis; iii. Perform lipidomic and fatty acid profiling of adipose tissues. - Evaluate associations between imaging metrics, markers of AT dysfunction, the tumor molecular profile, and clinical outcomes including overall survival and response to therapy. Primary Objective 3: To assess the role of AT-PDAC interactions in influencing tumor growth, metastasis, and therapeutic response. Secondary Objectives: - Leverage ex vivo culture techniques using patient paired PDAC-AT samples to identify AT-secreted lipids that impact PDAC cell growth, metastasis, and lipolysis in vitro. - To employ co-culture systems and ex vivo sensitivity assays to i. identify unique treatment targets and strategies and ii. evaluate novel combinations of FDA-approved agents against PDAC avatars.

• Treatments

  Therapies:

  Observational

  Medications:

  Not Applicable ()

• Inclusion Criteria

  Inclusion Criteria:
  • Adults 18 years of age or older
  • Patients who self-report as African American or Non-Hispanic White, and present to the gastrointestinal (GI) clinic, surgery, or endoscopy at a participating FPC site or UMMC with a clinical suspicion or diagnosis of a pancreatic tumor will be eligible. For tissue obtained through routine diagnostic procedures, confirmation is made by the institutional pathologist.

• Exclusion Criteria

  Exclusion Criteria:
  • No suspicion or diagnosis of a pancreatic cancer or tumor
  • Self-reported race/ethnicity other than Non-Hispanic White or African American

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