跳至主要内容
临床试验/NCT05687188
NCT05687188招募中不适用

Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations

H. Lee Moffitt Cancer Center and Research Institute2 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2023年2月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
125
试验地点
2
主要终点
Compare biological properties of Adipose Tissue dysfunction

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Retrospective Cohort

Retrospective chart review and sample analysis of both pathologically confirmed Pancreatic Ductal Adenocarcinoma (PDAC) cases and non-Cancer control cases.

Prospective Cohort

Blood samples, tissue samples and data will be collected from all participants as applicable.

干预措施: Blood Sample Collection (Other)

Prospective Cohort

Blood samples, tissue samples and data will be collected from all participants as applicable.

干预措施: Tissue Sample Collection (Other)

Prospective Cohort

Blood samples, tissue samples and data will be collected from all participants as applicable.

干预措施: Data Collection (Other)

Prospective Cohort

Blood samples, tissue samples and data will be collected from all participants as applicable.

干预措施: Medical Image Collection (Other)

结局指标

主要结局

Compare biological properties of Adipose Tissue dysfunction

时间窗: at 36 months

Investigators will compare biological properties of Adipose Tissue dysfunction between African American vs Non-Hispanic White participants.

Assess molecular and radiological landscape of traditional PDAC tumors in the context of Race/Ethnicity

时间窗: 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

Examine the role of Adipose Tissue and PDAC tumor interactions in influencing tumor growth, metastasis, and therapeutic response

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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