Blood Markers of Early Pancreas Cancer

January 29, 2026 updated by: University of Nebraska

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients diagnosed with pancreatic ductal adenocarcinoma (PDAC) have only an 10% chance of surviving 5 years after diagnosis. Most PDAC is advanced and not amenable to curative therapies at the time of diagnosis, owing to lack of symptoms in early disease, nonspecific symptoms when they do develop resulting in a delay in diagnosis. Identifying biomarkers of early 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 participants at higher than average risk of PDAC in order to generate clinical data and bank serial blood specimens. Participants will include individuals with family history of pancreas cancer, individuals with cystic pancreas lesions or chronic pancreatitis, and individuals with new-onset diabetes. Identifying specific biomarkers - blood markers and/or a clinical "prodrome" - in participants who go on to develop PDAC could improve the diagnostic approach outcomes for patients diagnosed with PDAC.

Study Type

Observational

Enrollment (Estimated)

1250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • Unversity of Nebraska Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

In order to obtain a resource of clinical data and longitudinally obtained, annotated blood specimens and to develop an enriched population to prospectively evaluate a sensitive and specific biomarker, subjects from the following 3 groups at higher than average risk of pancreatic ductal adenocarcinoma (PDAC) will be recruited and enrolled.

New onset diabetes, high risk pre-diabetes Pancreatic cystic neoplasms and pancreatitis Familial risk

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Diagnostic test: Mixed Meal Tolerance Test
The goal of the test is to determine hormone secretion from the pancreas and small intestine in response to the mixed meal.
Other Names:
  • MMTT
Diagnostic test: Hemoglobin A1c
This test provides the average level of blood glucose over the last 3 months.
Other Names:
  • Glycated Hemoglobin Test
  • Glycosylated Hemoglobin
Diagnostic test: Other exploratory blood biomarkers
Other exploratory blood biomarkers including cell free DNA and other markers in development
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
Diagnostic test: Hemoglobin A1c
This test provides the average level of blood glucose over the last 3 months.
Other Names:
  • Glycated Hemoglobin Test
  • Glycosylated Hemoglobin
Diagnostic test: Other exploratory blood biomarkers
Other exploratory blood biomarkers including cell free DNA and other markers in development
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
Diagnostic test: Hemoglobin A1c
This test provides the average level of blood glucose over the last 3 months.
Other Names:
  • Glycated Hemoglobin Test
  • Glycosylated Hemoglobin
Diagnostic test: Other exploratory blood biomarkers
Other exploratory blood biomarkers including cell free DNA and other markers in development

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of pancreas cancer cases diagnosed.
Time Frame: 10 years
Number of pancreas cancer cases diagnosed.
10 years
Biomarkers which may predict early pancreas cancer.
Time Frame: 10 years
Biomarkers which may predict early pancreas cancer.
10 years
Result of MMTT which may indicate type 3c diabetes, which may be a risk factor for pancreas cancer.
Time Frame: 10 years
Result of MMTT which may indicate type 3c diabetes, which may be a risk factor
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Collaborators

National Cancer Institute (NCI)
VA Nebraska Western Iowa Health Care System
Virginia Mason Hospital/Medical Center

Investigators

  • Principal Investigator: Kelsey A Klute, MD, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2018

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

June 13, 2018

First Submitted That Met QC Criteria

June 13, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0335-18-FB
  • U01CA210240-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Pancreatic Cancer Detection Consortium (PCDC) includes collaborators at several institutions, including UNMC, working to identify biomarkers and develop novel imaging techniques to identify pre-malignant and subclinical PDAC. One of the primary objectives of the consortium is to establish a repository of serial biospecimens collected from subjects prior to their diagnosis of PDAC. These specimens will be readily available when biomarkers in development are ready for validation. Due to the low incidence of pancreas cancer, even in groups at substantially increased risk, obtaining enough specimens to use for biomarker identification from those subjects who go on to develop PDAC requires collaborative effort between multiple institutions. This proposal is the contribution from UNMC to the consortium's biorepository effort.

IPD Sharing Time Frame

Data will be shared with the consortium on a rolling basis throughout the enrollment period.

IPD Sharing Access Criteria

Priority will be given to researchers affiliated with the PCDC. Primary investigators will review outside requests, which may be accepted on a case by case basis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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