Using Radiogenomics to Predict Malignant Potential of Intraductal Papillary Mucinous Neoplasms of the Pancreas

September 14, 2026 updated by: H. Lee Moffitt Cancer Center and Research Institute

Using Radiogenomics to Noninvasively Predict the Malignant Potential of Intraductal Papillary Mucinous Neoplasms (IPMNs) of the Pancreas and Uncover Hidden Biology

The Florida Pancreas Collaborative wants to partner with individuals who are known to have, or are suspected to have a pancreatic lesion, tumor, cyst, mass, cancer, or pancreatitis and are undergoing diagnosis and treatment at a participating institution. The goals of this project are to build a large database of information obtained from blood, tissue, medical images, surveys and information from routine care to develop noninvasive diagnostic approaches that could be used as decision-making tools to effectively personalize clinical care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1174

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Lakewood Rch, Florida, United States, 34211
        • Recruiting
        • Florida Research Institute (FRI)
        • Contact:
        • Principal Investigator:
          • Arun Khazanchi, MD
      • Miami, Florida, United States, 33136
        • Recruiting
        • Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Nipun B Merchant, MD, FACS
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Contact:
        • Principal Investigator:
          • Jennifer B Permuth, PhD, MS
        • Principal Investigator:
          • Daniel Jeong, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients of the GI clinic, surgery, or endoscopy at Moffitt Cancer Center, University of Florida - Gainesville, or the University of Miami - Jackson Memorial Hospital.

Description

Inclusion Criteria:

  • Individuals who present to the GI clinic, surgery, or endoscopy at Moffitt, Florida Research Institute (FRI), or UM with a clinical suspicion for (or diagnosis of) a pancreatic lesion, cyst, mass, cancer, or pancreatitis based on symptoms, imaging, or blood-work and has not had any treatment involving their pancreas.
  • Able to understand and voluntarily sign the informed consent.
  • Willing to complete study questionnaire(s) and donate medical images and/or biological specimens (including blood, cystic fluid, and/or tissue) obtained at the time of standard of care procedures (biopsy, surgery, and venipuncture) after signing the informed consent document

Exclusion Criteria:

  • No suspicion or diagnosis of a pancreatic lesion, cyst, mass, cancer, or pancreatitis.
  • Has a diagnosis of a pancreatic lesion, cyst, mass, cancer, or pancreatitis and has already undergone treatment involving the pancreas (which may involve surgery, chemo- or immuno-therapy, and/or radiation).
  • Unable to provide informed consent.
  • Unwilling to complete study questionnaire(s) and/or donate biological specimens or images.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Retrospective Cohort
Retrospective chart review of pathologically-confirmed Intraductal Papillary Mucinous Neoplasm (IPMN) cases
Prospective Cohort
Blood, tumor tissue samples and data will be collected.
Other: Blood Sample collection
Participants will be asked to donate blood at baseline (+/- 30 days of diagnosis date), 4-6 weeks post-surgery, if applicable, and at the time of follow-up (approximately 1 year and approximately 2 years after baseline).
Other: Tissue sample collection
At the time of tissue biopsy and surgical resection (if applicable), pancreatic tumor tissue, muscle, fat, tissue from site of metastasis, and cyst fluid (if applicable) will be collected.
Other: Data collection
Participants will be asked to complete questionnaires at baseline and at 1 year and 2 year follow-ups.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Predictive value of CT Radiomic features vs conventional radiologic features
Time Frame: Up to 2 years
Preoperative CT images will be evaluated for a retrospective cohort of at least 254 pathologically-confirmed IPMN cases (approximately 190 malignant characterized by high-grade dysplasia or invasion and approximately 64 benign characterized by low- or moderate-grade dysplasia). 3D-radiomic features will be extracted with the new Quantitative Imaging Decision Support (QIDS)™ platform (Healthmyne, Inc.) and associations will be evaluated with pathology.
Up to 2 years
Development of Clinical Decision Making Models for Predicting IPMN Pathology
Time Frame: Up to 2 years
Investigators will develop the first prototype preoperative 'omics'-based nomograms to predict IPMN pathology by integrating radiomic features, the MGC, and other covariates. Emphasis will be placed on developing nomograms for individuals whose IPMNs appear to have 'worrisome' radiologic features which are very challenging to manage.
Up to 2 years
Radiogenomic Analyses
Time Frame: Up to 2 years
Investigators will conduct the first radiogenomic analyses of IPMNs by evaluating the relationship between radiomic features and tissue and circulating levels of candidate biomarkers.
Up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Up to 4 years
Overall survival is defined as time from surgery to death from any cause.
Up to 4 years
Progression Free Survival
Time Frame: Up to 4 years
Progression free survival is defined as time from surgery to either pancreatic cancer recurrence or death.
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
University of Miami
University of Florida

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer Permuth, PhD, Moffitt Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 18, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MCC-20105
  • 1R37CA229810-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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