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

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Predictive value of CT Radiomic features vs conventional radiologic features [Time frame: Up to 2 years]
• Development of Clinical Decision Making Models for Predicting IPMN Pathology [Time frame: Up to 2 years]
• Radiogenomic Analyses [Time frame: Up to 2 years]

Secondary outcome measures (2)

• Overall Survival [Time frame: Up to 4 years]
• Progression Free Survival [Time frame: Up to 4 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

United States · 3 centers

• Florida Research Institute (FRI) — Lakewood Rch
• Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital — Miami
• Moffitt Cancer Center — Tampa

Identifiers

NCT: NCT04275557 · MCC-20105 · 1R37CA229810-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗