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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05687188




Registration number
NCT05687188
Ethics application status
Date submitted
6/01/2023
Date registered
18/01/2023
Date last updated
1/10/2024

Titles & IDs
Public title
Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations
Scientific title
Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations
Secondary ID [1] 0 0
PA210192, W81XWH2211021
Secondary ID [2] 0 0
MCC-21962
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Blood Sample Collection
Other interventions - Tissue Sample Collection
Other interventions - Data Collection
Other interventions - Medical Image Collection

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 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.

Other interventions: 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.

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

Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assess molecular and radiological landscape of traditional PDAC tumors in the context of Race/Ethnicity
Timepoint [1] 0 0
at 36 months
Primary outcome [2] 0 0
Compare biological properties of Adipose Tissue dysfunction
Timepoint [2] 0 0
at 36 months
Primary outcome [3] 0 0
Examine the role of Adipose Tissue and PDAC tumor interactions in influencing tumor growth, metastasis, and therapeutic response
Timepoint [3] 0 0
at 36 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
125
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Mississippi

Funding & Sponsors
Primary sponsor type
Other
Name
H. Lee Moffitt Cancer Center and Research Institute
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
United States Department of Defense
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate obesity-mediated mechanisms of pancreatic carcinogenesis in minority populations.
Trial website
https://clinicaltrials.gov/study/NCT05687188
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Jennifer Permuth, PhD, MS
Address 0 0
Moffitt Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05687188