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| ID | Type | Description | Link |
|---|---|---|---|
| 1R37CA229810-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| University of Florida | OTHER |
| University of Miami | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival is defined as time from surgery to death from any cause. | Up to 4 years |
| Progression Free Survival | Progression free survival is defined as time from surgery to either pancreatic cancer recurrence or death. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients of the GI clinic, surgery, or endoscopy at Moffitt Cancer Center, University of Florida - Gainesville, or the University of Miami - Jackson Memorial Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toni Basinski, MS | Contact | 813-745-6360 | Toni.Basinski@moffitt.org |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Permuth, PhD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Research Institute (FRI) | Recruiting | Lakewood Rch | Florida | 34211 | United States |
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| Label | URL |
|---|---|
| Moffitt Cancer Center website | View source |
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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)
| 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. |
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| Data collection | Other | Participants will be asked to complete questionnaires at baseline and at 1 year and 2 year follow-ups. |
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| Up to 4 years |
| Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital | Recruiting | Miami | Florida | 33136 | United States |
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| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D010181 | Pancreatic Cyst |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D003560 | Cysts |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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