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Active, not recruitingNCT04275557Updated Sep 23, 2026

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

An observational study in Pancreatic Cancer and Pancreatic Cyst, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Active, not recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Observational

Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
1,274
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Pancreatic Cancer
  • Pancreatic Cyst

Keywords

  • Pancreatic Lesions
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In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 1,274 is above the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.
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Study design

Observational model
Case-only
Time perspective
Other
Enrollment
1,274 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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 · Other: Tissue sample collection · Other: Data collection

Interventions

  • OtherBlood 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).

  • OtherTissue 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.

  • OtherData collection

    Participants will be asked to complete questionnaires at baseline and at 1 year and 2 year follow-ups.

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What researchers measure

Primary outcomes

  1. Predictive value of CT Radiomic features vs conventional radiologic features

    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.

    Time frame: Up to 2 years

  2. Development of Clinical Decision Making Models for Predicting IPMN Pathology

    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.

    Time frame: Up to 2 years

  3. Radiogenomic Analyses

    Investigators will conduct the first radiogenomic analyses of IPMNs by evaluating the relationship between radiomic features and tissue and circulating levels of candidate biomarkers.

    Time frame: Up to 2 years

Secondary outcomes

  1. Overall Survival

    Overall survival is defined as time from surgery to death from any cause.

    Time frame: Up to 4 years

  2. Progression Free Survival

    Progression free survival is defined as time from surgery to either pancreatic cancer recurrence or death.

    Time frame: Up to 4 years

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Study locations

3 sites
  • Florida Research Institute (FRI)
    Lakewood Rch, Florida 34211, United States
  • Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital
    Miami, Florida 33136, United States
  • Moffitt Cancer Center
    Tampa, Florida 33612, United States
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References and documents

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04275557
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI), University of Florida, University of Miami
Responsible party
Sponsor
First posted
Feb 19, 2020
Start date
Feb 18, 2020
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Sep 23, 2026

Study contacts

Jennifer Permuth, PhD
principal investigator · Moffitt Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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