Clinical trial · Observational
Diagnostic Potential of Hypermethylated DNA in Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aberrant DNA Methylation | — | UNRESOLVED | — |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (5)
- label
- CRC group (exploratory)
- description
- Blood samples from approximately 210 patients diagnosed with colorectal carcinoma collected prospectively and consecutively at the Department of Surgical Gastroenterology, Aalborg University Hospital during the time period 2003-2006 will be used. The blood samples were collected at the time of diagnosis, before and after treatment (surgery and radio-chemo-therapy) and at regular intervals for a time period of two years after treatment. These blood samples were collected during a previous PhD-study: "Pre- and postoperative Venous Thromboembolism in Patients with Colorectal Cancer - implications of Radiotherapy" (ID-number VN 2003/102).
- label
- Control group (exploratory)
- description
- Blood samples (8ml) from patients (n=142) who underwent work-up for lower gastrointestinal malignancy during the time period 2003-2006. Colonoscopy was performed, and no malignancy or premalignant lesions found. Blood samples were collected before/after colonoscopy. These blood samples were collected during a previous PhD-study: "Pre- and postoperative Venous Thromboembolism in Patients with Colorectal Cancer - implications of Radiotherapy" (ID-number VN 2003/102).
- label
- CRC group (validation)
- description
- Blood samples from 143 patients were collected prospectively and consecutively for a previous study on the effect of omega 3 fatty acids an postoperative complications after colorectal surgery. All study participants have provided written informed consent (N-VN-20050035).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available