About this trial
This study will evaluate obesity-mediated mechanisms of pancreatic carcinogenesis in minority populations.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients at a Florida Pancreas Collaborative site who identify as African American or Non-Hispanic White.
Trial design
Cohort
Prospective
Treatments tested in this trial
Blood Sample Collection
Other interventionParticipants 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 interventionAt 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 interventionParticipants will complete a study questionnaire at baseline that includes medical history, lifestyle, and family history information.
Medical Image Collection
Other interventionMedical 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Compare biological properties of Adipose Tissue dysfunction
Investigators will compare biological properties of Adipose Tissue dysfunction between African American vs Non-Hispanic White participants.
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.
Sponsors and contacts
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H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
United States Department of Defense
Collaborator