Actively Recruiting

Age: 19Years +
All Genders
Healthy Volunteers
ID03568630

A Longitudinal Cohort Study to Identify Clinical and Blood Markers of Early Pancreas Cancer

Led by University of Nebraska · Updated on 2026-02-02

1250

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Nebraska

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting a longitudinal study to identify early blood markers and clinical signs of pancreatic ductal adenocarcinoma (PDAC), a form of pancreas cancer with a very low survival rate due to late diagnosis. The study focuses on people at higher than average risk, including those with family history, certain pancreas conditions, or new-onset diabetes, to improve early detection and outcomes. Participants are grouped based on risk factors: new onset or high-risk pre-diabetes, pancreatic cystic lesions or chronic pancreatitis, and inherited genetic risks. The study involves collecting clinical data and banking blood samples over time to find biomarkers that may predict early pancreas cancer and related diabetes changes. Participants will attend in-person visits twice a year in Omaha, NE, for blood sample collection and clinical assessments. The study will track the number of pancreas cancer cases diagnosed, explore blood markers linked to early cancer, and evaluate tests indicating diabetes related to pancreas cancer risk over a 10-year period. This long-term observation aims to support earlier diagnosis and better management of PDAC.

CONDITIONS

Brief Title

Blood Markers of Early Pancreas Cancer

Who Can Participate

Age: 19Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 19 years or older
  • Able to provide written, informed consent
  • Able to attend in-person study visits in Omaha, NE twice a year to collect blood samples
  • Must meet criteria for at least one specific group: new onset diabetes/high-risk pre-diabetes, pancreatic cystic neoplasm/pancreatitis, or inherited risk
  • New onset diabetes/high-risk pre-diabetes group: Diagnosed with type 2 diabetes within past 3 years (A1c 65 6.5%, fasting glucose >126 mg/dL) or high-risk pre-diabetes (A1c >6.3% or A1c >6.0% with fasting glucose >110 or abnormal glucose tolerance test) or on metformin less than 3 years
  • Pancreatic cystic neoplasm/pancreatitis group: Pancreatic cystic lesion requiring monitoring or chronic pancreatitis diagnosed by imaging, testing, or gastroenterologist
  • Inherited risk group: Two or more blood relatives with pancreatic ductal adenocarcinoma, or one first-degree relative diagnosed before age 60, or relevant germline mutation associated with higher pancreas cancer risk, or personal/family history meeting hereditary cancer syndrome criteria
Not Eligible

You will not qualify if you...

  • Personal history of pancreatic ductal adenocarcinoma (PDAC)
  • Currently receiving treatment for any cancer (except long-term hormonal therapy)
  • Pre-diabetes treated with metformin for 3 years or more

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 10 years

Participants at higher risk of pancreatic cancer are observed with regular blood sample collections and clinical assessments to identify early markers of pancreatic ductal adenocarcinoma.

Visits twice a year (in-person) for blood sample collection

Trial Site Locations

Total: 1 location

1

Unversity of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Actively Recruiting

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Research Team

S

Suzanne M Wessling, RN, BSN

K

Kelsey A Klute, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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