Recruiting

Observational Study

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT05687188

Conditions

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blood Sample Collection

Tissue Sample Collection

Data Collection

Medical Image Collection

Study Details

Brief summary:

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

Conditions

Pancreatic Cancer

Study ID

NCT05687188

Start date

Feb 22, 2023

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

125 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Assess molecular and radiological landscape of traditional PDAC tumors in the context of Race/Ethnicity [ Time Frame: at 36 months ]
  • Compare biological properties of Adipose Tissue dysfunction [ Time Frame: at 36 months ]
  • Examine the role of Adipose Tissue and PDAC tumor interactions in influencing tumor growth, metastasis, and therapeutic response [ Time Frame: at 36 months ]

Central Contacts and Locations

Locations

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Magdeline D Martin

352-672-0548MDMartin@umc.edu

Principal Investigator:

Shannon Orr, MD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • pancreas
  • biomarkers
  • health disparities

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-05-26.