DNA Promoter Hypermethylation as a Blood Based Maker for Pancreatic Cancer
NCT ID: NCT02079363
Last Updated: 2014-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
330 participants
OBSERVATIONAL
2013-08-31
2018-01-31
Brief Summary
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* a diagnostic marker for pancreatic cancer
* a prognostic marker for pancreatic cancer
* a marker for recurrence of pancreatic cancer
* changing during the course of chronic pancreatitis, with the purpose of finding patients with high risk of developing pancreatic cancer
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Detailed Description
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Patients with resectable tumors and no co-morbidity, have a 5-year survival rate up to 54 %. This indicates that early detection of the disease, which enables complete surgical resection of the tumor, is a way to improve survival. Chronic pancreatitis is one of the only known risk factors for PCa.
Currently there is no valid diagnostic marker for PCa. Diagnosis requires advanced methods and several of these are invasive and entail a risk of complications. A blood-based marker for pancreatic cancer would be a major achievement and of great benefit to the patients, and may even be used in screening.
During development of cancer changes in DNA arise, including DNA hypermethylation where a methyl residue is attached to the DNA. The methylation most frequently occurs in the regulatory region of the gene leading to inactivity. Some of the inactivated genes are necessary to ensure the control of cell growth. When these genes are inactivated, the cell will no longer be subject to normal control mechanisms and may eventually develop into a cancer cell.
Small amounts of DNA are released into the blood and can be detected in a blood sample. The DNA changes may be tumor specific and potentially useable as a marker for PCa. In 2012 our research unit in cooperation with Department of Molecular Diagnostic, Aalborg University Hospital published an optimized method for detection of hypermethylated DNA in plasma. The method has greatly improved sensitivity.
The purpose of our study is to test whether alterations in DNA hypermethylations in blood can be used as:
* A diagnostic marker for pancreatic cancer.
* A prognostic marker for pancreatic cancer.
* A marker for recurrence.
* Monitoring patients with chronic pancreatitis and detecting patients with particularly high risk of developing pancreatic cancer.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with pancreatic adenocarcinoma
Exclusion criteria:
No prior cancer. No anticoagulant treatment.
No interventions, this is an observational study
Patients with chronic pancreatitis
Exclusion criteria:
No prior cancer. No anticoagulant treatment.
No interventions, this is an observational study
Patients with acute pancreatitis
Exclusion criteria:
No prior cancer.
No interventions, this is an observational study
Patients screened for but not having upper GI cancer
Exclusion criteria:
No prior cancer.
No interventions, this is an observational study
Interventions
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No interventions, this is an observational study
Eligibility Criteria
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Inclusion Criteria
* Patients hospitalized at Aalborg University Hospital, with acute pancreatitis verified by UL, CT or MR-scan and/or increased s-amylase
Exclusion Criteria
* Anticoagulant therapy.
* Immunological tissue disease.
18 Years
ALL
No
Sponsors
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Aalborg University Hospital
OTHER
Responsible Party
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Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery
MD, DMSc, Consultant surgeant, Professor of Surgery
Principal Investigators
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Stine Dam Henriksen, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Gastrointestinal Surgery, Aalborg University Hospital, Denmark
Ole Thorlacius-Ussing, MD,DMSc,Prof
Role: STUDY_CHAIR
Department of Gastrointestinal Surgery, Aalborg University Hospital, Denmark
Locations
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Research unit, Surgical Department of Gastroenterology, Aalborg University Hospital
Aalborg, , Denmark
Countries
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Central Contacts
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June Lundtoft
Role: CONTACT
Facility Contacts
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References
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Park JW, Baek IH, Kim YT. Preliminary study analyzing the methylated genes in the plasma of patients with pancreatic cancer. Scand J Surg. 2012;101(1):38-44. doi: 10.1177/145749691210100108.
Melson J, Li Y, Cassinotti E, Melnikov A, Boni L, Ai J, Greenspan M, Mobarhan S, Levenson V, Deng Y. Commonality and differences of methylation signatures in the plasma of patients with pancreatic cancer and colorectal cancer. Int J Cancer. 2014 Jun 1;134(11):2656-62. doi: 10.1002/ijc.28593. Epub 2013 Nov 29.
Park JK, Ryu JK, Yoon WJ, Lee SH, Lee GY, Jeong KS, Kim YT, Yoon YB. The role of quantitative NPTX2 hypermethylation as a novel serum diagnostic marker in pancreatic cancer. Pancreas. 2012 Jan;41(1):95-101. doi: 10.1097/MPA.0b013e318221c903.
Liggett T, Melnikov A, Yi QL, Replogle C, Brand R, Kaul K, Talamonti M, Abrams RA, Levenson V. Differential methylation of cell-free circulating DNA among patients with pancreatic cancer versus chronic pancreatitis. Cancer. 2010 Apr 1;116(7):1674-80. doi: 10.1002/cncr.24893.
Jiao L, Zhu J, Hassan MM, Evans DB, Abbruzzese JL, Li D. K-ras mutation and p16 and preproenkephalin promoter hypermethylation in plasma DNA of pancreatic cancer patients: in relation to cigarette smoking. Pancreas. 2007 Jan;34(1):55-62. doi: 10.1097/01.mpa.0000246665.68869.d4.
Yi JM, Guzzetta AA, Bailey VJ, Downing SR, Van Neste L, Chiappinelli KB, Keeley BP, Stark A, Herrera A, Wolfgang C, Pappou EP, Iacobuzio-Donahue CA, Goggins MG, Herman JG, Wang TH, Baylin SB, Ahuja N. Novel methylation biomarker panel for the early detection of pancreatic cancer. Clin Cancer Res. 2013 Dec 1;19(23):6544-6555. doi: 10.1158/1078-0432.CCR-12-3224. Epub 2013 Oct 2.
Henriksen SD, Madsen PH, Larsen AC, Johansen MB, Drewes AM, Pedersen IS, Krarup H, Thorlacius-Ussing O. Cell-free DNA promoter hypermethylation in plasma as a diagnostic marker for pancreatic adenocarcinoma. Clin Epigenetics. 2016 Nov 16;8:117. doi: 10.1186/s13148-016-0286-2. eCollection 2016.
Other Identifiers
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Hypmet
Identifier Type: -
Identifier Source: org_study_id
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