- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2018-07-26
2028-07
2028-07
1250
NCT03568630
University of Nebraska
University of Nebraska
OBSERVATIONAL
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.
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-06-13 | N/A | 2025-02-06 |
2018-06-13 | N/A | 2025-02-10 |
2018-06-26 | N/A | 2025-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | 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-diab | |
| : 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 test | |
| : 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 av |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of pancreas cancer cases diagnosed. | Number of pancreas cancer cases diagnosed. | 10 years |
| Biomarkers which may predict early pancreas cancer. | 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. | Result of MMTT which may indicate type 3c diabetes, which may be a risk factor | 10 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Suzanne M Wessling, RN, BSN Phone Number: 402-559-1577 Email: suzanne.wessling@unmc.edu |
Study Contact Backup Name: Kelsey A Klute, MD Phone Number: 402-559-8500 Email: kelsey.klute@unmc.edu |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
19 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
