Blood Markers of Early Pancreas Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorUniversity of Nebraska

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,250 Participants
are grouped into 3 trial groups
Group A: New Onset Diabetes/High-Risk Prediabetes
Group B: Pancreatic Cystic Neoplasm/Pancreatitis
Group C: Inherited Risk

Trial outcomes

Primary outcomes

1

Number of pancreas cancer cases diagnosed.

Number of pancreas cancer cases diagnosed.

Time frame
10 years
2

Biomarkers which may predict early pancreas cancer.

Biomarkers which may predict early pancreas cancer.

Time frame
10 years
3

Result of MMTT which may indicate type 3c diabetes, which may be a risk factor for pancreas cancer.

Result of MMTT which may indicate type 3c diabetes, which may be a risk factor

Time frame
10 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nebraska

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Virginia Mason Hospital/Medical Center

Collaborator

VA Nebraska Western Iowa Health Care System

Collaborator