DNA Promoter Hypermethylation as a Blood Based Maker for Pancreatic Cancer

Trial Title: DNA Promoter Hypermethylation as a Blood Based Maker for Pancreatic Cancer

NCT ID: NCT02079363

Condition: Pancreatic Diseases
Pancreatic Neoplasms
Pancreatitis

Conditions: Official terms:
Pancreatic Neoplasms
Pancreatitis
Pancreatic Diseases

Conditions: Keywords:
Pancreatic Diseases
Pancreatic Neoplasms
Pancreatitis
DNA promoter hypermethylation
DNA methylation
Cell-free DNA
Plasma

Study type: Observational

Overall status: Unknown status

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: No interventions, this is an observational study
Arm group label: Patients screened for but not having upper GI cancer
Arm group label: Patients with acute pancreatitis
Arm group label: Patients with chronic pancreatitis
Arm group label: Patients with pancreatic adenocarcinoma

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.

Criteria for eligibility:

Study pop:
Patients with pancreatic adenocarcinoma, who were referred to Aalborg University Hospital between 2008 and 2012. Blodsamples are stored in a biobank. Patients with chronic pancreatitis, who are hospitalized or have an outpatient visit at Aalborg University Hospital. Patients with acute pancreatitis, who are hospitalized at Aalborg University Hospital. Patients who are referred to Aalborg University Hospital for suspected upper GI cancer. Subsequent examinations invalidate the cancer diagnosis.

Sampling method: Non-Probability Sample
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

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Research unit, Surgical Department of Gastroenterology, Aalborg University Hospital

Address:
City: Aalborg
Zip: 9000
Country: Denmark

Status: Recruiting

Contact:
Last name: Stine Dam Henriksen, MD

Phone: +45 97661210
Email: stdh@rn.dk

Start date: August 2013

Completion date: January 2018

Lead sponsor:
Agency: Aalborg University Hospital
Agency class: Other

Source: Aalborg University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT02079363