DNA Promoter Hypermethylation as a Blood Based Maker for Pancreatic Cancer

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Brief Title

DNA Promoter Hypermethylation as a Blood Based Maker for Pancreatic Cancer

Official Title

Cell-free DNA Promoter Hypermethylation in Plasma From Patients With Pancreatic Adenocarcinoma, Compared to Patients With Pancreatitis and Pancreatitis and Patients Screened for, But Not Having Pancreatic Adenocarcinoma."

Brief Summary

      The objectives of this project are to test whether alteration in DNA hypermethylation in
      plasma is:

        -  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
    

Detailed Description

      Pancreatic cancer (PCa) is one of the most deadly cancers with a 5-year survival rate of less
      than 10 %. The majority of PCa are found to be none-resectable at the time of diagnosis. Only
      10 - 20% of patients are offered surgical treatment, which is the only chance of cure. The
      mean survival times of none-resected patients are 3 to 6 months. Despite surgical treatment
      many patients experience recurrence. The high overall mortality is mainly caused by
      difficulties in early diagnosis due to unspecific/lack of symptoms in the early stages of the
      disease.

      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.
    


Study Type

Observational


Primary Outcome

Number of methylated genes for each participant.

Secondary Outcome

 Number of methylated genes for each participant related to prognosis

Condition

Pancreatic Diseases

Intervention

No interventions, this is an observational study

Study Arms / Comparison Groups

 Patients with pancreatic adenocarcinoma
Description:  Exclusion criteria:
No prior cancer. No anticoagulant treatment.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

330

Start Date

August 2013

Completion Date

January 2018

Primary Completion Date

August 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with chronic pancreatitis who are hospitalized or have an outpatient visit at
             Aalborg University Hospital Or

          -  Patients hospitalized at Aalborg University Hospital, with acute pancreatitis verified
             by UL, CT or MR-scan and/or increased s-amylase

        Exclusion Criteria:

          -  Prior cancer history.

          -  Anticoagulant therapy.

          -  Immunological tissue disease.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Stine Dam Henriksen, MD, +45 97661210, [email protected]

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT02079363

Organization ID

Hypmet


Responsible Party

Principal Investigator

Study Sponsor

Aalborg University Hospital


Study Sponsor

Stine Dam Henriksen, MD, Principal Investigator, Department of Gastrointestinal Surgery, Aalborg University Hospital, Denmark


Verification Date

July 2014