Colorectal Neoplasms Clinical Trial
Official title:
Diagnostic Potential of Hypermethylated DNA in Colorectal Cancer
Colorectal cancer (CRC) is one of the most common forms of cancer and the second leading
cause of cancer-related deaths in the western world.
CRC mortality is related to stage of disease with a five year survival for early-stage
disease of 77.0% and 50.8% for late stage disease. Methods for early detection of primary as
well as recurrent CRC are therefore important to increase patient survival. Tumour
biomarkers from blood, stool, or urine could aid the early diagnostics of CRC, but despite
extensive research such markers have only provided limited clinical value.
Sporadic CRC develops as a result of the accumulation of genetic and epigenetic alterations.
Epigenetic alterations include DNA hypermethylation, which through transcriptional silencing
of tumour suppressor genes is associated with cancer development and cancer progression. The
search for gene promoter regions hypermethylated in cancer has been ongoing for nearly two
decades, and a number of genes have been shown to be preferentially hypermethylated in CRC.
Therefore, hypermethylated DNA in plasma has been suggested as a marker for tumour-stage and
survival in CRC patients. The only approved biomarker for the detection of CRC recurrence is
the protein carcinoembryonic antigen (CEA). CEA is limited by its low sensitivity and
therefore not recommended as a diagnostic biomarker. Hypermethylation of CRC specific genes
as part of a molecular biomarker panel measured in blood could prove to be a recurrence
marker in CRC patients, with elevated sensitivity and specificity.
The aims of this project are to examine if hypermethylation of specific genes measured from
cell-free DNA in plasma of CRC patients can be used to detect primary CRC, to detect CRC
recurrence and to be a biomarker for CRC prognosis.
Development of a reliable sensitive and specific biomarker for CRC will immensely improve
the diagnostics and handling of CRC patients.
Status | Recruiting |
Enrollment | 658 |
Est. completion date | September 2018 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients followed in the outpatient clinic with ulcerative colitis at Aalborg University Hospital. - Patients with a positive fecal occult blood test, referred for colonoscopy Exclusion Criteria: - Prior cancer history - Previous total colectomy |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Gastrointestinal Surgery | Aalborg |
Lead Sponsor | Collaborator |
---|---|
Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic potential of hypermethylated DNA as a biomarker for colorectal cancer | Through the analysis of cell-free DNA, we will develop a diagnostic prediction model for colorectal cancer using hypermethylated DNA as a biomarker. Hypermethylation status will be analysed using real time PCR. The model will be developed using plasma samples from 193 colorectal cancer patients and 102 healthy controls. The subsequent validation of the model, will be conducted, using plasma samples from 143 colorectal cancer patients, and roughly 100 colonoscopy verified healthy controls. In the validation study, we will also analyse plasma samples from roughly 100 patients with ulcerative colitis, in order to make sure, that the model can distinguish these patients from the other groups. | At the time of inclusion | No |
Secondary | Prognostic potential of hypermethylated DNA for colorectal cancer stage | Through the analysis of cell-free DNA, we will develop a prognostic prediction model for colorectal cancer stage, and survival. Plasma samples from 193 colorectal cancer patients with different stages of cancer will be used in the model development. Hypermethylation status will be analysed using real time PCR. Using logistic regression, a prediction model for late-stage cancer will be developed. Moreover, survival analysis will be used to evaluate if DNA hypermethylation measured in plasma could be a prognostic tool in colorectal cancer. | From the time of inclusion up to five years | No |
Secondary | Hypermethylated DNA as a follow-up biomarker for disease recurrence | Through the analysis of consecutive bloodsamples from 193 colorectal cancer patients, we will evaluate if hypermethylated DNA could be utilised as a follow-up biomarker for colorectal cancer reucurrence after surgery. | From the time of inclusion and to the time of recurrence, or five years | No |
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