Blood Markers of Early Pancreas Cancer
Study Details
Study Description
Brief Summary
Identifying biomarkers of early pancreatic ductal adenocarcinoma (PDAC) could facilitate screening for individuals at higher than average risk and expedite the diagnosis in individuals with symptoms and substantially improve an individual's chance of surviving the disease.
The investigators propose a longitudinal study of subjects at higher than average risk of PDAC in order to generate clinical data and bank serial blood specimens.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
Patients diagnosed with pancreatic ductal adenocarcinoma (PDAC) have only an 10% chance of surviving 5 years after diagnosis. Most PDAC is advanced and not amenable to curative therapies at the time of diagnosis, owing to lack of symptoms in early disease, nonspecific symptoms when they do develop resulting in a delay in diagnosis. Identifying biomarkers of early PDAC could facilitate screening for individuals at higher than average risk and expedite the diagnosis in individuals with symptoms and substantially improve an individual's chance of surviving the disease.
The investigators propose a longitudinal study of subjects at higher than average risk of PDAC in order to generate clinical data and bank serial blood specimens. Subjects will include individuals with family history of pancreas cancer, individuals with cystic pancreas lesions or chronic pancreatitis, and individuals with new-onset diabetes. Identifying specific biomarkers - blood markers and/or a clinical "prodrome" - in participants who go on to develop PDAC could improve the diagnostic approach outcomes for patients diagnosed with PDAC.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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New Onset Diabetes/High-Risk Prediabetes Must meet one of the following criteria: New onset type 2 diabetes diagnosed within the past 3 years, defined as Hemoglobin A1c ≥ 6.5%*, fasting blood glucose >126mg/dL confirmed on a subsequent day or as diagnosed by a physician High-risk pre-diabetes: Hemoglobin A1c >6.3% or A1c >6.0% with fasting blood glucose >110 or 2 hour oral glucose tolerance test between 140-200mg/dL; subjects who have been on metformin <3 years are eligible |
Diagnostic Test: Mixed Meal Tolerance Test
The goal of the test is to determine hormone secretion from the pancreas and small intestine in response to the mixed meal.
Other Names:
Diagnostic Test: Hemoglobin A1c
This test provides the average level of blood glucose over the last 3 months.
Other Names:
Diagnostic Test: Other exploratory blood biomarkers
Other exploratory blood biomarkers including cell free DNA and other markers in development
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Pancreatic Cystic Neoplasm/Pancreatitis Must meet one of the following criteria: Pancreatic cystic neoplasm for which resection, endoscopic ultrasound or serial imaging has been recommended Chronic pancreatitis as defined by cross-sectional imaging, endoscopic ultrasound, functional testing abnormalities OR as diagnosed by a gastroenterologist |
Diagnostic Test: Hemoglobin A1c
This test provides the average level of blood glucose over the last 3 months.
Other Names:
Diagnostic Test: Other exploratory blood biomarkers
Other exploratory blood biomarkers including cell free DNA and other markers in development
|
Inherited Risk Must meet one of the following criteria: Two or more blood relatives with PDAC (includes 1st-3rd degree relatives as defined in Table 2) One 1st degree relative with PDAC diagnosed before age 60 Germline mutation associated with a higher than average risk of PDAC including but not limited to the following: Hereditary breast and ovarian cancer syndromes BRCA1, BRCA2, PALB2 Hereditary nonpolyposis colon cancer (Lynch) syndrome MLH1, MSH2, MSH6, PMS2 Familial adenomatous polyposis (APC) Familial atypical multiple melanoma and mole syndrome CKDN2a, p16 Peutz-Jeghers syndrome STK11 Ataxia-telangiectasia ATM Juvenile polyposis syndromes SMAD4, BMPR1A Li Fraumeni TP53 Cystic fibrosis and unaffected carriers CFTR Personal or family history which meets clinical criteria for a hereditary cancer syndrome and includes a relative with PDAC |
Diagnostic Test: Hemoglobin A1c
This test provides the average level of blood glucose over the last 3 months.
Other Names:
Diagnostic Test: Other exploratory blood biomarkers
Other exploratory blood biomarkers including cell free DNA and other markers in development
|
Outcome Measures
Primary Outcome Measures
- Number of pancreas cancer cases diagnosed. [5 years]
- Biomarkers which may predict early pancreas cancer. [5 years]
- Result of MMTT which may indicate type 3c diabetes, which may be a risk factor for pancreas cancer. [5 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
General inclusion criteria:
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Age ≥19
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Able to provide written, informed consent
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Able to to attend an in-person study visit in Omaha, NE twice a year
Exclusion Criteria:
General exclusion criteria:
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Personal history of PDAC
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Currently receiving treatment for a cancer diagnosis (excluding long-term hormonal therapy)
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Pre-diabetes on metformin for ≥ 3 years
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Nebraska Medical Center | Omaha | Nebraska | United States | 68198 |
Sponsors and Collaborators
- University of Nebraska
- National Cancer Institute (NCI)
- Virginia Mason Hospital/Medical Center
- VA Nebraska Western Iowa Health Care System
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 335-18