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| Name | Class |
|---|---|
| BPGbio | INDUSTRY |
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This sample-collection study is open to participants in several categories: healthy volunteers (with or without a family history of pancreatic cancer) and individuals diagnosed with pancreatitis or any stage of pancreatic cancer. All participants will submit urine, saliva and blood samples; pancreatitis and pancreatic cancer patients will also submit tissue samples if biopsy/ies or surgery is part of the care being provided by their doctor. In partnership with Berg Health, LLC, biomarkers will be investigated for potential use in early detection of pancreatic cancer, to determine prognosis of patients, and to find the most appropriate treatments for patients.
The Primary Objective of this study is to identify and validate biomarkers that can be used for early detection and selection of personalized treatment of pancreatic diseases, including adenocarcinoma and pancreatitis. A maximum of 600 subjects will be enrolled in this study, including healthy volunteers, subjects with acute and chronic pancreatitis, family members at risk for pancreatic cancer (as defined below), and subjects with all stages of pancreatic adenocarcinoma who will contribute samples annotated with longitudinal clinical data. Biomarkers will be investigated for potential as Theranostic, Prognostic, Diagnostic and Therapeutic indicators among subjects with pancreatitis and pancreatic cancer.
Examples of eligible participants include:
Consented and enrolled subjects will be asked to participate in this study in the following ways:
Subsequent liquid non-tissue samples will be collected from all subjects at the following clinically-relevant time points related to standard of care treatment for pancreatic disease:
Blood (serum, plasma, and buffy coat), urine and saliva will not be collected more than six (6) times in a 12 month period per subject.
Samples will be collected until the subject withdraws or the study has completed enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy | Healthy volunteers without any known pancreatic disease | ||
| Healthy At-Risk | Healthy volunteers with no known benign or malignant pancreatic disease, AND with one first-degree relative with pancreatic cancer, OR two second-degree relatives with pancreatic cancer. These subjects also include those who have undergone surgery for suspected pancreatic cancer, and who are found to have a non-pancreatic cancer pathology upon final local site or central pathology review. | ||
| Pancreatitis | Subjects diagnosed with acute or chronic pancreatitis | ||
| Early Stage/Borderline/Locally Advanced | Subjects diagnosed with early stage pancreatic cancer who undergo surgery as standard of care therapy with or without preoperative (neoadjuvant) chemotherapy and/or radiation therapy; subjects diagnosed with borderline pancreatic cancer, or subjects diagnosed with locally advanced pancreatic cancer. | ||
| Metastatic | Subjects diagnosed with metastatic pancreatic cancer and treated with any standard of care therapy/therapies. |
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| Measure | Description | Time Frame |
|---|---|---|
| Berg's Interrogative Biology® Platform | Tissue and fluid samples will be analyzed using Berg's Interrogative Biology® Platform, which uses biomolecular analyses paired with artificial intelligence to identify and validate biomarkers that can be used for early detection of pancreatic diseases, including pancreatic cancer, and to determine the prognosis of patients, and best therapeutic treatment for specific patients. | Sample analysis will occur throughout enrollment period (5 years), and outcomes will be assessed at end of enrollment period. |
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Inclusion Criteria:
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
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This study will enroll participants in several categories:
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| Name | Affiliation | Role |
|---|---|---|
| A. James Moser, MD | Beth Israel Deaconess Medical Center, Harvard University | Principal Investigator |
| Tomislav Dragovich, MD | Banner Health - MD Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Health - MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| Mayo Clinic - Arizona |
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| Label | URL |
|---|---|
| Project Survival Patient Information Webpage | View source |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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Blood (serum, plasma, buffy coat), saliva, urine, and pancreatic tissue designated as surgical waste by site's treating pathologist.
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Mercy Health - St. Mary's | Grand Rapids | Michigan | 49503 | United States |
| Virginia Piper Cancer Institute - Allina Health | Minneapolis | Minnesota | 55407 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| D004066 |
| Digestive System Diseases |
| D004700 | Endocrine System Diseases |