NCT06076811Recruiting
DANISH.MRD: Danish Assessment of Minimal Residual Disease by Liquid Biopsies
Danish Assessment of Minimal Residual Disease by Liquid Biopsies
Source: ClinicalTrials.gov · Last updated 4 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1600 (estimated)
- First submitted
- 4 Oct 2023
- Start date
- 1 Aug 2023
- Primary completion date
- 30 Jul 2028
- Lead sponsor
- University of Aarhus
- Diseases
- Colorectal cancer
- NCT number
- NCT06076811
What you commit to
- Study type: Observational
- Planned participants: 1600
- From 1 Aug 2023 to the primary completion date, 30 Jul 2028
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Not treated with adjuvant chemotherapy
- Treated with neoadjuvant chemo-radiation therapy.
Other illness
- Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome.
- Inflammatory bowel disease (Crohn's disease or ulcerative colitis).
- Malignant colorectal polyps diagnosed after polypectomy.
- 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.
Other
- Verified distant metastases.
- 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
- 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.
Who the study is looking for
- 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).
- 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).
Criteria the registry did not label
- DANISH.MRD part I - Surgery
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Recruiting |
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
| Bispebjerg Hospital Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| Herlev Hospital Coordinator of this site? Confirm its status | Herlev | Denmark | Not yet recruiting |
| Gødstrup Hospital Coordinator of this site? Confirm its status | Herning | Denmark | Recruiting |
| Regional Hospital Horsens Coordinator of this site? Confirm its status | Horsens | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Recruiting |
| Regional Hospital Randers Coordinator of this site? Confirm its status | Randers | Denmark | Recruiting |
| Vejle Hospital Coordinator of this site? Confirm its status | Vejle | Denmark | Recruiting |
| Regional Hospital Viborg Coordinator of this site? Confirm its status | Viborg | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.