Approximately two-thirds of all colorectal cancer patients undergo surgery with the aim of curing them. However, despite the surgery, 20-25% of them experience relapse. It is possible to reduce the risk of relapse with chemotherapy, but as chemotherapy is associated with significant side effects, it is only given to patients at high risk of relapse. Currently, the risk is assessed based on an examination of the removed tumor tissue.
In a previous research project, blood samples were taken after patients' surgery and examined for the presence of circulating tumor DNA (ctDNA). When cancer cells in solid tumors die, they release DNA, which can be detected in the blood. DNA in the blood has a half-life of less than 2 hours, so if ctDNA is found in a blood sample taken, e.g., 14 days after surgery, the patient most likely still has cancer cells in their body.
The results show that if a patient has ctDNA in their blood after surgery, the risk of relapse is high. The presence of ctDNA in the blood has the potential to be a better indicator of the risk of future relapse than the tumor examination used today. Therefore, ctDNA analysis has the potential to become a marker that will be used in the future clinical setting for monitoring colorectal cancer.
The overall objective of this study is to confirm that ctDNA found in a blood sample after intended curative treatment for CRC is a marker of residual disease and risk of recurrence and is applicable in clinical practice.
Colon or rectal cancer, clinical tumor stage I-III.
Patient able to understand and sign written informed consent.
Scheduled for curative-intent resectional surgery (including "compromised" curative resections).
Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome.
Inflammatory bowel disease (Crohn's disease or ulcerative colitis).
Verified distant metastases.
Malignant colorectal polyps diagnosed after polypectomy.
DANISH.MRD part I - Surgery Patients with colorectal cancer clinical stage I-III scheduled for curative-intent resectional surgery. DANISH.MRD part I - Surveillance Patients participating in DANISH.MRD part 1, and pathological stage III colorectal cancer, and candidates for adjuvant chemotherapy.
Cohort
Prospective
Not listed
The prognostic value of ctDNA status
Especially, the association between 3-year disease-free survival and ctDNA status after surgery and after adjuvant chemotherapy
Ranking of commercial ctDNA diagnostics
Technical assessment to compare and rank commercial ctDNA diagnostics and evaluate their performance after surgery and adjuvant chemotherapy
Change in ctDNA levels after adjuvant chemotherapy
Assessment of the effect of standard-of-care chemotherapy on the level of ctDNA
Lead time between molecular and clinical recurrence
Assessment of the time between molecular recurrence (ctDNA positive blood sample) and clinical recurrence (standard-of-care radiological imaging)
Correlation between ctDNA analysis and findings on CT scans
ctDNA status on blood samples coinciding with standard-of-care CT scans (at 1 and 3 years after surgery), to see if ctDNA analysis can predict the outcome of the CT scan
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University of Aarhus
Lead sponsor
Aarhus University Hospital
Collaborator
