Using Radiogenomics to Predict Malignant Potential of Intraductal Papillary Mucinous Neoplasms of the Pancreas
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04275557|
Recruitment Status : Recruiting
First Posted : February 19, 2020
Last Update Posted : March 3, 2021
|Condition or disease||Intervention/treatment|
|Pancreatic Cancer Pancreatic Cyst||Other: Blood Sample collection Other: Tissue sample collection Other: Data collection|
|Study Type :||Observational|
|Estimated Enrollment :||1174 participants|
|Official Title:||Using Radiogenomics to Noninvasively Predict the Malignant Potential of Intraductal Papillary Mucinous Neoplasms (IPMNs) of the Pancreas and Uncover Hidden Biology|
|Actual Study Start Date :||February 18, 2020|
|Estimated Primary Completion Date :||February 2025|
|Estimated Study Completion Date :||February 2027|
Retrospective chart review of pathologically-confirmed Intraductal Papillary Mucinous Neoplasm (IPMN) cases
Blood, tumor tissue samples and data will be collected.
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.
- Predictive value of CT Radiomic features vs conventional radiologic features [ Time Frame: 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.
- Development of Clinical Decision Making Models for Predicting IPMN Pathology [ Time Frame: 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.
- Radiogenomic Analyses [ Time Frame: 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.
- Overall Survival [ Time Frame: Up to 4 years ]Overall survival is defined as time from surgery to death from any cause.
- Progression Free Survival [ Time Frame: Up to 4 years ]Progression free survival is defined as time from surgery to either pancreatic cancer recurrence or death.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04275557
|Contact: Karla Ali, MPH||813-745-1060||Karla.Ali@moffitt.org|
|Contact: Kaleena Dezsi, PhD||813-745-6612||Kaleena.Dezsi@moffitt.org|
|United States, Florida|
|University of Florida - Gainesville||Not yet recruiting|
|Gainesville, Florida, United States, 32610-0109|
|Contact: Jose G Trevino, MD, FACS 352-265-0761 Jose.Trevino@surgery.ufl.edu|
|Principal Investigator: Jose G Trevino, MD, FACS|
|Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Nipun B Merchant, MD, FACS 305-243-7160 firstname.lastname@example.org|
|Principal Investigator: Nipun B Merchant, MD, FACS|
|Moffitt Cancer Center||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Kaleena Dezsi, PhD 813-745-6612 Kaleena.Dezsi@moffitt.org|
|Principal Investigator: Jennifer B Permuth, PhD, MS|
|Principal Investigator: Daniel Jeong, MD|
|Principal Investigator:||Jennifer Permuth, PhD||Moffitt Cancer Center|