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

Recruiting

• Conditions: Pancreatic Cancer; Pancreatic Cyst
• Interventions: Other: Blood Sample collection; Other: Tissue sample collection; Other: Data collection

• Registration Number: NCT04275557
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-17
• Study Start: 2020-02-18
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-06
• Primary Completion: 2026-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1174

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective Cohort	Blood Sample collection	Blood, tumor tissue samples and data will be collected.
Prospective Cohort	Data collection	Blood, tumor tissue samples and data will be collected.
Prospective Cohort	Tissue sample collection	Blood, tumor tissue samples and data will be collected.

Primary Outcome Measures

Name	Time	Method
Predictive value of CT Radiomic features vs conventional radiologic features	Up to 2 years	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.
Radiogenomic Analyses	Up to 2 years	Investigators will conduct the first radiogenomic analyses of IPMNs by evaluating the relationship between radiomic features and tissue and circulating levels of candidate biomarkers.
Development of Clinical Decision Making Models for Predicting IPMN Pathology	Up to 2 years	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Up to 4 years	Overall survival is defined as time from surgery to death from any cause.
Progression Free Survival	Up to 4 years	Progression free survival is defined as time from surgery to either pancreatic cancer recurrence or death.

Trial Locations

Locations (3)

Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital; 🇺🇸 Miami, Florida, United States

Florida Research Institute (FRI); 🇺🇸 Lakewood Ranch, Florida, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States