Pancreatic CancerNCT05687188
Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations
An observational study of Pancreatic Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.
Trial summary
This study will evaluate obesity-mediated mechanisms of pancreatic carcinogenesis in minority populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Blood Sample Collection, Tissue Sample Collection and Data Collection
- How many people
- 185 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Feb 2023to Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at a Florida Pancreas Collaborative site who identify as African American or Non-Hispanic White.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
This study will evaluate obesity-mediated mechanisms of pancreatic carcinogenesis in minority populations.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Blood Sample Collection, Tissue Sample Collection, Data Collection, Medical Image Collection
- Keywords
- pancreas, biomarkers, health disparities
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Sample CollectionOther
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 CollectionOther
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 CollectionOther
Participants will complete a study questionnaire at baseline that includes medical history, lifestyle, and family history information.
Medical Image CollectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood Sample Collection; Other: Tissue Sample Collection; Other: Data Collection; Other: Medical Image Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: at 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start22 Feb 2023
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Jennifer Permuth, PhD, MS, Principal investigator, Moffitt Cancer CenterMokenge Malafa, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687188
- Sponsor's protocol ID
- MCC-21962
- Other IDs
- PA210192, W81XWH2211021
- Status last verified
- Sep 2026
- First submitted
- 6 Jan 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations
- ClinicalTrials.gov ID
- NCT05687188
- Acronym / sponsor ID
- MCC-21962
- Conditions
- Pancreatic Cancer
- Keywords
- pancreas, biomarkers, health disparities
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 185 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | – | –Retrospective chart review and sample analysis of both pathologically confirmed Pancreatic Ductal Adenocarcinoma (PDAC) cases and non-Cancer control cases. |
| Prospective Cohort | – | Other: Blood Sample Collection, Other: Tissue Sample Collection, Other: Data Collection, Other: Medical Image CollectionBlood samples, tissue samples and data will be collected from all participants as applicable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at a Florida Pancreas Collaborative site who identify as African American or Non-Hispanic White.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Sample CollectionParticipants 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 | Prospective Cohort |
| Tissue Sample CollectionAt 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 | Prospective Cohort |
| Data CollectionParticipants will complete a study questionnaire at baseline that includes medical history, lifestyle, and family history information. | Other | Prospective Cohort |
| Medical Image CollectionMedical 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. | Other | Prospective Cohort |
Primary outcome
Assess molecular and radiological landscape of traditional PDAC tumors in the context of Race/Ethnicity
Time frame: at 36 months
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
Time frame: at 36 months
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
Time frame: at 36 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Permuth, PhD, MS principal investigator
Moffitt Cancer Center
Mokenge Malafa, MD principal investigator
Moffitt Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess molecular and radiological landscape of traditional PDAC tumors in the context of Race/Ethnicity (time frame: at 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.