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 : April 10, 2020

See Contacts and Locations

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

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

Genetics Home Reference related topics: Hereditary pancreatitis

MedlinePlus related topics: Pancreatic Cancer

Genetic and Rare Diseases Information Center resources: Pancreatic Cancer

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
New Onset Diabetes/High-Risk Prediabetes Must meet one of the following criteria: 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 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: Pancreatic cystic neoplasm for which resection, endoscopic ultrasound or serial imaging has been recommended 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: Two or more blood relatives with PDAC (includes 1st-3rd degree relatives as defined in Table 2) One 1st degree relative with PDAC diagnosed before age 60 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 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

Primary Outcome Measures :

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.

Eligibility Criteria

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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:

Age ≥19
Able to provide written, informed consent

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

Contacts and Locations

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: Christina L Hoy, DNP	402-559-1577	christina.hoy@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: Christina Hoy, DNP 402-559-1577 christina.hoy@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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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:	April 10, 2020
Last Verified:	April 2020
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 Prediabetic State 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

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