Trial Title:
Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations
NCT ID:
NCT05687188
Condition:
Pancreatic Cancer
Conditions: Official terms:
Carcinogenesis
Conditions: Keywords:
pancreas
biomarkers
health disparities
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Blood Sample Collection
Description:
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.
Arm group label:
Prospective Cohort
Intervention type:
Other
Intervention name:
Tissue Sample Collection
Description:
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.
Arm group label:
Prospective Cohort
Intervention type:
Other
Intervention name:
Data Collection
Description:
Participants will complete a study questionnaire at baseline that includes medical
history, lifestyle, and family history information.
Arm group label:
Prospective Cohort
Intervention type:
Other
Intervention name:
Medical Image Collection
Description:
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.
Arm group label:
Prospective Cohort
Summary:
This study will evaluate obesity-mediated mechanisms of pancreatic carcinogenesis in
minority populations.
Detailed 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.
Criteria for eligibility:
Study pop:
Patients at a Florida Pancreas Collaborative site who identify as African American or
Non-Hispanic White.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Toni Basinski, MS
Phone:
813-745-6360
Email:
Toni.Basinski@moffitt.org
Investigator:
Last name:
Jennifer Permuth, PhD, MS
Email:
Principal Investigator
Investigator:
Last name:
Mokenge Malafa, MD
Email:
Principal Investigator
Investigator:
Last name:
Dung-Tsa Chen, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Daniel Jeong, MD, MS
Email:
Sub-Investigator
Investigator:
Last name:
John Koomen, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Paul Stewart, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Jamie Teer, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Ghulam Rasool, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Marilyn Bui, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Kun Jiang, MD, PhD
Email:
Sub-Investigator
Facility:
Name:
University of Mississippi Medical Center
Address:
City:
Jackson
Zip:
39216
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Magdeline D Martin
Phone:
352-672-0548
Email:
MDMartin@umc.edu
Investigator:
Last name:
Shannon Orr, MD
Email:
Principal Investigator
Start date:
February 22, 2023
Completion date:
December 2026
Lead sponsor:
Agency:
H. Lee Moffitt Cancer Center and Research Institute
Agency class:
Other
Collaborator:
Agency:
United States Department of Defense
Agency class:
U.S. Fed
Source:
H. Lee Moffitt Cancer Center and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05687188
https://www.moffitt.org/clinical-trials-research/clinical-trials/
