Blood Markers of Early Pancreas Cancer
Recruiting now
Conditions studied: Diabetes Mellitus, Type 2, PreDiabetes, Pancreas Cyst, Chronic Pancreatitis, Genetic Predisposition to Disease, Inherited Disease
In brief
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.
Key facts
- Study ID
- NCT03568630
- Run by
- University of Nebraska
- People needed
- 1250
- Starts
- 2018-07-26
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2026-02-02
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age ≥19
- Able to provide written, informed consent
- Able to attend an in-person study visit in Omaha, NE twice a year to collect blood samples
- Must also meet criteria for one specific cohort. Participants who meet criteria for more than one cohort are eligible. (The intent being that potential participants must meet the criteria for at least one cohort, but are eligible if criteria are met for more than one cohort)
- o New onset diabetes/high-risk pre-diabetes cohort: must meet one of the following criteria: New onset type 2 diabetes diagnosed within the past 3 years, defined as A1c ≥ 6.5%, fasting blood glucose >126mg/dL confirmed on a subsequent day or as diagnosed by a physician High-risk pre-diabetes: A1c >6.3% or A1c >6.0% with fasting blood glucose >110 or 2 hour oral glucose tolerance test between 140-200mg/dL, or taken metformin <3 years
- o Pancreatic cystic neoplasm/pancreatitis cohort: must have one of the following diagnoses: Pancreatic cystic neoplasm for which resection, endoscopic ultrasound (EUS) 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
- o Inherited risk cohort: must meet one of the following criteria: Two or more blood relatives with pancreatic ductal adenocarcinoma (PDAC), includes 1st-3rd degree relatives (First - parent, sibling or child; Second - grandparent, aunt/uncle, niece/nephew, or half-sibling; Third - first cousin, great grand parent or great grandchild) 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: 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-telangectasia (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 (as above)
You may not qualify if…
- Personal history of pancreatic ductal adenocarcinoma (PDAC)
- Currently receiving treatment for a cancer diagnosis (excluding long-term hormonal therapy)
- Pre-diabetes on metformin for ≥ 3 years
Where it is running
- Unversity of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
Full record on ClinicalTrials.gov
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