Recruiting

Observational Study

Sponsor:

University of Nebraska

Code:

NCT03568630

Conditions

Diabetes Mellitus, Type 2

PreDiabetes

Pancreas Cyst

Chronic Pancreatitis

Genetic Predisposition to Disease

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Diabetes Mellitus, Type 2

PreDiabetes

Pancreas Cyst

Chronic Pancreatitis

Genetic Predisposition to Disease

Study ID

NCT03568630

Start date

Jul 26, 2018

Status verified date

Jan, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

1250 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

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 ]
  • Biomarkers which may predict early pancreas cancer. [ Time Frame: 10 years ]
  • Result of MMTT which may indicate type 3c diabetes, which may be a risk factor for pancreas cancer. [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Suzanne M Wessling, RN, BSN

402-559-1577suzanne.wessling@unmc.edu

Kelsey A Klute, MD

402-559-8500kelsey.klute@unmc.edu

Locations

Unversity of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Suzanne M Wessling, RN, BSN

402-559-1577suzanne.wessling@unmc.edu

More Information

Sponsor

University of Nebraska

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-02-02.