Blood Markers of Early Pancreas Cancer

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT03568630
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Accepted

Study Details

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 Dates

Start date
Jul 26, 2018
Status verified
Jan 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
1,250 participants (estimated)

Arms

  • Arm: New Onset Diabetes/High-Risk Prediabetes
    Must meet one of the following criteria: 1. 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 2. 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
  • Arm: Pancreatic Cystic Neoplasm/Pancreatitis
    Must meet one of the following criteria: 1. Pancreatic cystic neoplasm for which resection, endoscopic ultrasound or serial imaging has been recommended 2. Chronic pancreatitis as defined by cross-sectional imaging, endoscopic ultrasound, functional testing abnormalities OR as diagnosed by a gastroenterologist
  • Arm: Inherited Risk
    Must meet one of the following criteria: 1. Two or more blood relatives with PDAC (includes 1st-3rd degree relatives as defined in Table 2) 2. One 1st degree relative with PDAC diagnosed before age 60 3. 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 4. Personal or family history which meets clinical criteria for a hereditary cancer syndrome and includes a relative with PDAC

Primary Outcome Measure

Number of pancreas cancer cases diagnosed. [ Time Frame: 10 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Unversity of Nebraska Medical CenterOmahaNebraska68198
Suzanne M Wessling, RN, BSN
[email protected]
402-559-1577

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Unversity of Nebraska Medical Center· Omaha, NE

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