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Using Radiogenomics to Predict Malignant Potential of Intraductal Papillary Mucinous Neoplasms of the Pancreas
NCT04275557 · H. Lee Moffitt Cancer Center and Research Institute
In plain English
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Official title
Using Radiogenomics to Noninvasively Predict the Malignant Potential of Intraductal Papillary Mucinous Neoplasms (IPMNs) of the Pancreas and Uncover Hidden Biology
About this study
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.
Eligibility criteria
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 design
Enrollment target: 1174 participants
Age groups: adult, older_adult
Timeline
Starts: 2020-02-18
Estimated completion: 2027-06
Last updated: 2025-12-04
Interventions
Other: Blood Sample collectionOther: Tissue sample collectionOther: Data collection
Primary outcomes
- • Predictive value of CT Radiomic features vs conventional radiologic features (Up to 2 years)
- • Development of Clinical Decision Making Models for Predicting IPMN Pathology (Up to 2 years)
- • Radiogenomic Analyses (Up to 2 years)
Sponsor
H. Lee Moffitt Cancer Center and Research Institute · other
With: National Cancer Institute (NCI), University of Florida, University of Miami
Contacts & investigators
ContactToni Basinski, MS · contact · Toni.Basinski@moffitt.org · 813-745-6360
InvestigatorJennifer Permuth, PhD · principal_investigator, Moffitt Cancer Center
All locations (3)
Florida Research Institute (FRI)Recruiting
Lakewood Rch, Florida, United States
Sylvester Comprehensive Cancer Center & Jackson Memorial HospitalRecruiting
Miami, Florida, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States