Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations

Pancreatic Cancer Clinical Trial

Official title:

Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05687188
• Other study ID #: MCC-21962
• Secondary ID: PA210192, W81XWH
• Status: Recruiting
• Start date: February 22, 2023
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinogenesis
• Pancreatic Cancer

Intervention

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

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess molecular and radiological landscape of traditional PDAC tumors in the context of Race/Ethnicity	Investigators will compare gene prevalence, type and expression of genetic mutations and radiomic features in African American participants vs Non-Hispanic White participants	at 36 months
Primary	Compare biological properties of Adipose Tissue dysfunction	Investigators will compare biological properties of Adipose Tissue dysfunction between African American vs Non-Hispanic White participants.	at 36 months
Primary	Examine the role of Adipose Tissue and PDAC tumor interactions in influencing tumor growth, metastasis, and therapeutic response	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.	at 36 months

External Links

•   Moffitt Cancer Center Clinical Trials website