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2013-08
2017-08
2018-01
330
NCT02079363
Aalborg University Hospital
Aalborg University Hospital
OBSERVATIONAL
DNA Promoter Hypermethylation as a Blood Based Maker for Pancreatic Cancer
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
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2014-03-04 | N/A | 2014-07-29 |
2014-03-04 | N/A | 2014-07-30 |
2014-03-05 | N/A | 2014-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Patients with pancreatic adenocarcinoma Exclusion criteria: No prior cancer. No anticoagulant treatment. | OTHER: No interventions, this is an observational study |
| : Patients with chronic pancreatitis Exclusion criteria: No prior cancer. No anticoagulant treatment. | OTHER: No interventions, this is an observational study |
| : Patients with acute pancreatitis Exclusion criteria: No prior cancer. | OTHER: No interventions, this is an observational study |
| : Patients screened for but not having upper GI cancer Exclusion criteria: No prior cancer. | OTHER: No interventions, this is an observational study |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of methylated genes for each participant. | We investigate the methylation status a of panel of 20 different genes in cell-free DNA in plasma. Plasma from patients with c. pancreas will be compared to plasma from patients in the control groups to se if DNA promoter hypermethylation can be used as a diagnostic marker for pancreas cancer. | Time of diagnosis |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of methylated genes for each participant related to prognosis | We investigate the methylation status a of panel of 20 different genes in cell-free DNA in plasma. Number of methylated genes will be investigated in relation to TNM- classification, tumor-size and time of survival. | 2 years follow up |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Stine Dam Henriksen, MD Phone Number: +45 97661210 Email: stdh@rn.dk |
Study Contact Backup Name: June Lundtoft Phone Number: +45 97661131 Email: |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
