Actively Recruiting
DANISH.MRD: Danish Assessment of Minimal Residual Disease by Liquid Biopsies
Led by University of Aarhus · Updated on 2026-02-04
1600
Participants Needed
10
Research Sites
365 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DANISH.MRD: Danish Assessment of Minimal Residual Disease by Liquid Biopsies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Colon or rectal cancer at clinical tumor stage I-III
- Able to understand and sign written informed consent
- Scheduled for curative-intent resectional surgery
- Participation in DANISH.MRD part I - Surgery for part II
- Colorectal cancer UICC stage III for part II
- Received curative-intent surgery and candidate for 3- or 6-month adjuvant chemotherapy for part II
You will not qualify if you...
- 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
- Unlikely to comply with study protocol or complete the study
- Not treated with adjuvant chemotherapy for part II
- Treated with neoadjuvant chemo-radiation therapy for part II
- Synchronous colorectal and non-colorectal cancer diagnosed during surgery (except non-melanoma skin cancer) for part II
- Other cancers (excluding colorectal or non-melanoma skin cancer) within 3 years from eligibility screening for part II
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Bispebjerg Hospital
Copenhagen, Capital Region of Denmark, Denmark, 2400
Actively Recruiting
2
Herlev Hospital
Herlev, Capital Region of Denmark, Denmark, 2730
Not Yet Recruiting
3
Aarhus University Hospital
Aarhus, Central Jutland, Denmark, 8000
Actively Recruiting
4
Gødstrup Hospital
Herning, Central Jutland, Denmark, 7400
Actively Recruiting
5
Regional Hospital Horsens
Horsens, Central Jutland, Denmark, 8700
Actively Recruiting
6
Regional Hospital Randers
Randers, Central Jutland, Denmark, 8930
Actively Recruiting
7
Regional Hospital Viborg
Viborg, Central Jutland, Denmark, 8800
Actively Recruiting
8
Aalborg University Hospital
Aalborg, North Denmark, Denmark, 9000
Actively Recruiting
9
Odense University Hospital
Odense, The Region of Southern Denmark, Denmark, 5000
Actively Recruiting
10
Vejle Hospital
Vejle, Denmark, 7100
Actively Recruiting
Research Team
C
Claus L Andersen, PhD
CONTACT
C
Christina Demuth, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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