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

NCT04275557 | Recruiting

• 2 other identifiers: MCC-201051R37CA229810-01A1
• Study Type: observational
• Target: 1,174
• Locations: 1 country
• Sites: 3

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.

Conditions

Pancreatic Cancer; Pancreatic Cyst

Keywords

Pancreatic Lesions

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Up to 2 years

Secondary Outcomes (2)

• Overall Survival

  Up to 4 years

• Progression Free Survival

  Up to 4 years

Study Arms (2)

Retrospective Cohort

Retrospective chart review of pathologically-confirmed Intraductal Papillary Mucinous Neoplasm (IPMN) cases

Prospective Cohort

Blood, tumor tissue samples and data will be collected.

Other: Blood Sample collection; Other: Tissue sample collection; Other: Data collection

Interventions

Blood Sample collection OTHER

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).

Prospective Cohort

Tissue sample collection OTHER

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.

Prospective Cohort

Data collection OTHER

Participants will be asked to complete questionnaires at baseline and at 1 year and 2 year follow-ups.

Prospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of the GI clinic, surgery, or endoscopy at Moffitt Cancer Center, University of Florida - Gainesville, or the University of Miami - Jackson Memorial Hospital.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Cancer Institute (NCI): collaborator
• University of Florida: collaborator
• University of Miami: collaborator

Study Sites (3)

Florida Research Institute (FRI)

Lakewood Rch, Florida, 34211, United States

RECRUITING

Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital

Miami, Florida, 33136, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Related Links

• Moffitt Cancer Center website

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood, Plasma, Serum, Tumor tissue from biopsy or surgery, Muscle and fat tissue from surgery, cyst fluid, cytology supernatant, peripheral blood monocular cells (PMBCs)

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatic Cyst

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Cysts

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jennifer Permuth, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Toni Basinski, MS

CONTACT

813-745-6360; Toni.Basinski@moffitt.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 19, 2020
• Study Start: February 18, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

US (3)