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NCT Number: NCT05687188

Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Moffitt Cancer Center, Tampa, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Sample Collection

Other

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.

Tissue sample collection

Other

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.

Data Collection

Other

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

Medical Image Collection

Other

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.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • United States Department of Defense

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 18, 2023
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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