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

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ClinicalTrials.gov Identifier: NCT04275557
Recruitment Status : Recruiting
First Posted : February 19, 2020
Last Update Posted : June 3, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of Florida
University of Miami
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Pancreatic Cancer Pancreatic Cyst Other: Blood Sample collection Other: Tissue sample collection Other: Data collection

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Study Type : Observational
Estimated Enrollment : 1174 participants
Observational Model: Case-Only
Time Perspective: Other
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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 :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to 4 years ]
    Overall survival is defined as time from surgery to death from any cause.

  2. 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
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)


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Individuals who present to the GI clinic, surgery, or endoscopy at Moffitt, UF, 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 biological specimens (including blood, cystic fluid, and 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Karla Ali, MPH 813-745-1060 Karla.Ali@moffitt.org
Contact: Kaleena Dezsi, PhD 813-745-6612 Kaleena.Dezsi@moffitt.org

Locations
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United States, Florida
Florida Research Institute (FRI) Not yet recruiting
Lakewood Ranch, Florida, United States, 34211
Contact: Arun Khazanchi, MD    941-727-7772    arun.khazanchi@fdhs.com   
Principal Investigator: Arun Khazanchi, MD         
Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Nipun B Merchant, MD, FACS    305-243-7160    nmerchant@miami.edu   
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         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
University of Florida
University of Miami
Investigators
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Principal Investigator: Jennifer Permuth, PhD Moffitt Cancer Center
Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT04275557    
Other Study ID Numbers: MCC-20105
1R37CA229810-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 19, 2020    Key Record Dates
Last Update Posted: June 3, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Pancreatic Lesions
Additional relevant MeSH terms:
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Neoplasms
Pancreatic Cyst
Digestive System Diseases
Pancreatic Diseases
Cysts