Clinical Trial 20105

• Overview

  Study Title:

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

  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.

  Objective:

  The goal of this project is to fulfill the unmet need to discover a noninvasive biomarker and imaging approach that has greater accuracy in predicting IPMN pathology than conventional radiologic and clinical features, thereby enhancing clinical decision-making and promoting more good than harm for patients at-risk to harbor or develop early PC. Aim 1) To determine the diagnostic performance and stability of preoperative CT radiomic features (compared to conventional radiologic features) in predicting IPMN pathology in a) a retrospective series and b) an independent, multi-institutional prospective series. Aim 2) To develop clinical decision-making models for predicting IPMN pathology. Aim 3) To conduct the first radiogenomic analyses of IPMNs by evaluating the relationship between radiomic features and tissue and circulating levels of candidate biomarkers.

• Inclusion 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

  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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