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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
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Virginia Mason Hospital/Medical Center
VA Nebraska Western Iowa Health Care System
Information provided by (Responsible Party):
Kelsey Klute, University of Nebraska

Study Description
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Brief 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.


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

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 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 Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Chrysarobin

Groups and Cohorts
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. Number of pancreas cancer cases diagnosed. [ Time Frame: 5 years ]
  2. Biomarkers which may predict early pancreas cancer. [ Time Frame: 5 years ]
  3. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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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
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 PDAC will be recruited and enrolled.

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

Criteria

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

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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
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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

Locations
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United States, Nebraska
Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Suzanne Wessling, RN, BSN    402-559-1577    suzanne.wessling@unmc.edu   
Sponsors and Collaborators
University of Nebraska
National Cancer Institute (NCI)
Virginia Mason Hospital/Medical Center
VA Nebraska Western Iowa Health Care System
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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