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Blood Markers of Early Pancreas Cancer

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ClinicalTrials.gov Identifier: NCT03568630
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : November 19, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kelsey Klute, University of Nebraska

Tracking Information
First Submitted Date June 13, 2018
First Posted Date June 25, 2018
Last Update Posted Date November 19, 2018
Actual Study Start Date July 26, 2018
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 13, 2018)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03568630 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Blood Markers of Early Pancreas Cancer
Official Title A Longitudinal Cohort Study to Identify Clinical and Blood Markers of Early Pancreas Cancer
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.

Detailed Description

Patients diagnosed with pancreatic ductal adenocarcinoma (PDAC) have only an 8% 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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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.

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

Condition
  • Diabetes Mellitus, Type 2
  • PreDiabetes
  • Pancreas Cyst
  • Chronic Pancreatitis
  • Genetic Predisposition to Disease
  • Inherited Disease
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.
    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
Study Groups/Cohorts
  • 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
    Interventions:
    • Diagnostic Test: Mixed Meal Tolerance Test
    • Diagnostic Test: Hemoglobin A1c
    • Diagnostic Test: Other exploratory blood biomarkers
  • 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
    Interventions:
    • Diagnostic Test: Hemoglobin A1c
    • Diagnostic Test: Other exploratory blood biomarkers
  • 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
    Interventions:
    • Diagnostic Test: Hemoglobin A1c
    • Diagnostic Test: Other exploratory blood biomarkers
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 13, 2018)
1250
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

General inclusion criteria:

  1. Age ≥19
  2. Able to provide written, informed consent

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
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Christina L Hoy, DNP 402-559-1577 christina.hoy@unmc.edu
Contact: Kelsey A Klute, MD 402-559-8500 kelsey.klute@unmc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03568630
Other Study ID Numbers 335-18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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.
Responsible Party Kelsey Klute, University of Nebraska
Study Sponsor University of Nebraska
Collaborators National Cancer Institute (NCI)
Investigators Not Provided
PRS Account University of Nebraska
Verification Date November 2018