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RecruitingObservational

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

NCT ID: NCT04275557Sponsor: H. Lee Moffitt Cancer Center and Research InstituteLast updated: 2025-12-04

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.

Arms & 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.

Outcome measures

Primary

  • 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

  • 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

  • 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

  • Overall Survival

    Time frame: Up to 4 years

  • Progression Free Survival

    Time frame: Up to 4 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (3)

Florida Research Institute (FRI)

Lakewood Rch, Florida, 34211

Recruiting
Arun Khazanchi, MD · Contact
941-727-7772arun.khazanchi@fdhs.com
Arun Khazanchi, MD · Principal Investigator

Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital

Miami, Florida, 33136

Recruiting
Nipun B Merchant, MD, FACS · Contact
305-243-7160nmerchant@miami.edu
Nipun B Merchant, MD, FACS · Principal Investigator

Moffitt Cancer Center

Tampa, Florida, 33612

Recruiting
Toni Basinski, MS · Contact
813-745-6360Toni.Basinski@moffitt.org
Jennifer B Permuth, PhD, MS · Principal Investigator
Daniel Jeong, MD · Principal Investigator