No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
19 and older
Sex
Any
Study type
Observational
Participants needed
1,250 (estimated)
Sponsor
University of Nebraska · Other
Who this trial is looking for
This trial is looking for people at higher risk for pancreatic cancer to help find blood markers that could improve early detection. Participants will need to visit Omaha, NE twice a year to provide blood samples.
Are You a Good Fit for This Trial?
You may be able to join if
I am 19 years or older
I can give written consent
I can visit Omaha, NE twice a year
I have new onset type 2 diabetes or high-risk pre-diabetes
I have a pancreatic cyst or chronic pancreatitis
I have family members with pancreatic cancer or a genetic risk
You may not be able to join if
I have had pancreatic cancer
I am currently being treated for cancer
I have been on metformin for 3 years or more
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
* 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…
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
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