Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations

NCT05687188 | Recruiting

• 2 other identifiers: MCC-21962PA210192, W81XWH2211021
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Pancreatic Cancer

Keywords

pancreas; biomarkers; health disparities

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

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.

Other: Blood Sample Collection; Other: Tissue Sample Collection; Other: Data Collection; Other: Medical Image Collection

Interventions

Blood Sample Collection 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.

Prospective Cohort

Tissue Sample Collection 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.

Prospective Cohort

Data Collection OTHER

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

Prospective Cohort

Medical Image Collection 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.

Prospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at a Florida Pancreas Collaborative site who identify as African American or Non-Hispanic White.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• United States Department of Defense: collaborator
• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (2)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

RECRUITING

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jennifer Permuth, PhD, MS

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

• Mokenge Malafa, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 18, 2023
• Study Start: February 22, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (2)