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Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations

NCT ID: NCT05687188

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-22

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pancreatic Cancer

Keywords

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pancreas biomarkers health disparities

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Retrospective Cohort

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

No interventions assigned to this group

Prospective Cohort

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

Blood Sample Collection

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

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

Medical Image Collection

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Data Collection

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Permuth, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Mokenge Malafa, MD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

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Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Facility Contacts

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Toni Basinski, MS

Role: primary

Magdeline D Martin

Role: primary

Other Identifiers

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PA210192, W81XWH2211021

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MCC-21962

Identifier Type: -

Identifier Source: org_study_id