Blood Markers of Early Pancreas Cancer

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03568630
• Other study ID #: 0335-18-FB
• Secondary ID: U01CA210240-06
• Status: Recruiting
• Start date: July 26, 2018
• Est. completion date: July 2028

Study information

• Verified date: February 2024
• Source: University of Nebraska
• Contact: Suzanne M Wessling, RN, BSN
• Phone: 402-559-1577
• Email: suzanne.wessling[@]unmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 subjects at higher than average risk of PDAC in order to generate clinical data and bank serial blood specimens. Subjects 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1250
• Est. completion date: July 2028
• Est. primary completion date: July 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

General inclusion criteria:

1. Age =19

2. Able to provide written, informed consent

3. Able to to attend an in-person study visit in Omaha, NE twice a year to collect blood samples

Exclusion Criteria:

General exclusion criteria:

1. Personal history of PDAC

2. Currently receiving treatment for a cancer diagnosis (excluding long-term hormonal therapy)

3. Pre-diabetes on metformin for = 3 years

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Diabetes Mellitus, Type 2
• Genetic Predisposition to Disease
• Inherited Disease
• Pancreas Cyst
• Pancreatic Cyst
• Pancreatic Neoplasms
• Pancreatitis
• Pancreatitis, Chronic
• PreDiabetes

Intervention

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.
• Hemoglobin A1c
This test provides the average level of blood glucose over the last 3 months.
• Other exploratory blood biomarkers
Other exploratory blood biomarkers including cell free DNA and other markers in development

Locations

Country	Name	City	State
United States	Unversity of Nebraska Medical Center	Omaha	Nebraska

Sponsors (4)

Lead Sponsor	Collaborator
University of Nebraska	National Cancer Institute (NCI), VA Nebraska Western Iowa Health Care System, Virginia Mason Hospital/Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of pancreas cancer cases diagnosed.	Number of pancreas cancer cases diagnosed.	10 years
Primary	Biomarkers which may predict early pancreas cancer.	Biomarkers which may predict early pancreas cancer.	10 years
Primary	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	10 years