Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations

Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Assess molecular and radiological landscape of traditional PDAC tumors in the context of Race/Ethnicity [Срок оценки: at 36 months]
• Compare biological properties of Adipose Tissue dysfunction [Срок оценки: at 36 months]
• Examine the role of Adipose Tissue and PDAC tumor interactions in influencing tumor growth, metastasis, and therapeutic response [Срок оценки: at 36 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 2 центра

• Moffitt Cancer Center — Tampa
• University of Mississippi Medical Center — Jackson

Идентификаторы

NCT: NCT05687188 · MCC-21962 · PA210192, W81XWH2211021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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