DANISH.MRD: Danish Assessment of Minimal Residual Disease by Liquid Biopsies

Summary

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.

Eligibility

DANISH.MRD part I - Surgery

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.
* Patients who are unlikely to comply with the protocol (e.g., uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study.

DANISH.MRD part II - Surveillance

Inclusion Criteria:

* Participation in DANISH.MRD part I - Surgery.
* Colorectal cancer, UICC stage III.
* Has received curative-intent resection and is a candidate for adjuvant chemotherapy (3- or 6-months regime).

Exclusion Criteria:

* Not treated with adjuvant chemotherapy
* Treated with neoadjuvant chemo-radiation therapy.
* Synchronous colorectal and non-colorectal cancer diagnosed per operative (except skin cancer other than melanoma).
* Other cancers (excluding colorectal cancer or skin cancer other than melanoma) within 3 years from eligibility screening.
* Patients who are unlikely to comply with the protocol (e.g., uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study.

Conditions7

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