Blood Markers of Early Pancreas Cancer
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ClinicalTrials.gov Identifier: NCT03568630 |
Recruitment Status :
Recruiting
First Posted : June 26, 2018
Last Update Posted : February 2, 2022
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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.
Condition or disease | Intervention/treatment |
---|---|
Diabetes Mellitus, Type 2 PreDiabetes Pancreas Cyst Chronic Pancreatitis Genetic Predisposition to Disease Inherited Disease | Diagnostic Test: Mixed Meal Tolerance Test Diagnostic Test: Hemoglobin A1c Diagnostic Test: Other exploratory blood biomarkers |
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.
Study Type : | Observational |
Estimated Enrollment : | 1250 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Longitudinal Cohort Study to Identify Clinical and Blood Markers of Early Pancreas Cancer |
Actual Study Start Date : | July 26, 2018 |
Estimated Primary Completion Date : | July 2023 |
Estimated Study Completion Date : | July 2023 |

Group/Cohort | Intervention/treatment |
---|---|
New Onset Diabetes/High-Risk Prediabetes
Must meet one of the following criteria:
|
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 Name: MMTT Diagnostic Test: Hemoglobin A1c This test provides the average level of blood glucose over the last 3 months.
Other Names:
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:
|
Diagnostic Test: Hemoglobin A1c
This test provides the average level of blood glucose over the last 3 months.
Other Names:
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:
|
Diagnostic Test: Hemoglobin A1c
This test provides the average level of blood glucose over the last 3 months.
Other Names:
Diagnostic Test: Other exploratory blood biomarkers Other exploratory blood biomarkers including cell free DNA and other markers in development |
- Number of pancreas cancer cases diagnosed. [ Time Frame: 5 years ]
- Biomarkers which may predict early pancreas cancer. [ Time Frame: 5 years ]
- Result of MMTT which may indicate type 3c diabetes, which may be a risk factor for pancreas cancer. [ Time Frame: 5 years ]
Biospecimen Retention: Samples With DNA
Detection of early PDAC will ideally use clinical and/or biochemical markers of early disease in combination with novel imaging techniques which can identify disease much earlier than with current modalities. This protocol will focus on clinical symptoms and blood biomarkers described below and will allow the study of novel biomarkers in development using banked blood specimens.
Identifying individuals with new-onset diabetes and/or diabetes in the setting of chronic pancreatitis, and who have clear evidence of type 3c diabetes may allow for targeted screening of these individuals, with Mixed Meal Tolerance Test, for pancreatic cancer in light of the high risk of cancer in these individuals.
Blood may be analyzed for other markers, including those currently in development and those which may be developed in the future.

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Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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 PDAC will be recruited and enrolled.
New onset diabetes, high risk pre-diabetes Pancreatic cystic neoplasms and pancreatitis Familial risk
Inclusion Criteria:
General inclusion criteria:
- Age ≥19
- Able to provide written, informed consent
- Able to to attend an in-person study visit in Omaha, NE twice a year
Exclusion Criteria:
General exclusion criteria:
- Personal history of PDAC
- Currently receiving treatment for a cancer diagnosis (excluding long-term hormonal therapy)
- Pre-diabetes on metformin for ≥ 3 years

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568630
Contact: Suzanne M Wessling, RN, BSN | 402-559-1577 | suzanne.wessling@unmc.edu | |
Contact: Kelsey A Klute, MD | 402-559-8500 | kelsey.klute@unmc.edu |
United States, Nebraska | |
Nebraska Medical Center | Recruiting |
Omaha, Nebraska, United States, 68198 | |
Contact: Suzanne Wessling, RN, BSN 402-559-1577 suzanne.wessling@unmc.edu |
Responsible Party: | Kelsey Klute, MD, Assistant Professor, Internal Medicine Oncology/Hematology, University of Nebraska |
ClinicalTrials.gov Identifier: | NCT03568630 |
Other Study ID Numbers: |
335-18 |
First Posted: | June 26, 2018 Key Record Dates |
Last Update Posted: | February 2, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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. |
Time Frame: | Data will be shared with the consortium on a rolling basis throughout the enrollment period. |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pancreatic Neoplasms Pancreatic Cyst Pancreatitis Pancreatitis, Chronic Diabetes Mellitus, Type 2 Disease Susceptibility Genetic Predisposition to Disease Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Pancreatic Diseases Digestive System Diseases Digestive System Neoplasms Neoplasms by Site |
Neoplasms Endocrine Gland Neoplasms Disease Attributes Pathologic Processes Cysts Chrysarobin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents |