Clinical trial NCT04275557: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cancer
Pancreatic Cyst
Keywords: Pancreatic Lesions
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of Florida
name: University of Miami
First posted: 2020-02-19
Enrollment: 1174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
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.

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.


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.

Primary outcomes:
measure: Predictive value of CT Radiomic features vs conventional radiologic features
timeFrame: Up to 2 years
measure: Development of Clinical Decision Making Models for Predicting IPMN Pathology
timeFrame: Up to 2 years
measure: Radiogenomic Analyses
timeFrame: Up to 2 years
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to 4 years
measure: Progression Free Survival
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Lakewood Ranch
country: United States
facility: Florida Research Institute (FRI)
state: Florida
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Jennifer Permuth, PhD
role: PRINCIPAL_INVESTIGATOR
References: