Actively Recruiting
Danish Assessment of Minimal Residual Disease by Liquid Biopsies for Colorectal Cancer Monitoring and Prognosis
Led by University of Aarhus · Updated on 2026-02-04
1600
Participants Needed
10
Research Sites
104 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
Colorectal cancer (CRC) is a common cancer where surgery aims to cure patients, but about 20-25% still experience relapse after surgery. Chemotherapy can lower relapse risk but has significant side effects, so it is only given to those at high risk. This research evaluates circulating tumor DNA (ctDNA) in blood as a new marker to detect residual cancer and predict relapse risk more accurately than current tumor tissue exams. The overall goal is to confirm ctDNA as a useful clinical tool for monitoring CRC after curative treatment. The study is divided into two parts: DANISH.MRD part I focuses on surgery, where blood samples are collected before and after surgery to detect ctDNA. Part II focuses on surveillance, with blood samples collected after adjuvant chemotherapy and during follow-up visits. Patients receive standard care alongside these tests. The study will assess ctDNA's prognostic value, compare ctDNA diagnostic methods, and explore ctDNA levels during and after chemotherapy, as well as their relation to clinical outcomes and imaging results. Participants contribute blood samples at specific times: before surgery, 20-30 days after surgery but before chemotherapy, after chemotherapy, and at regular intervals up to three years post-surgery. Tissue from surgery is also collected. Researchers will monitor disease-free survival over three years, compare ctDNA results with CT scans, and analyze molecular characteristics of the cancer. Patients receive standard follow-up care for up to five years. This comprehensive approach aims to improve early detection of relapse and guide treatment decisions.
CONDITIONS
Brief 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, clinical tumor stage I-III
- Able to understand and sign written informed consent
- Scheduled for curative-intent resectional surgery (including "compromised" curative resections)
- Participation in DANISH.MRD part I for surveillance phase
- Colorectal cancer UICC stage III for surveillance phase
- Received curative-intent resection and candidate for adjuvant chemotherapy (3- or 6-months regime) for surveillance phase
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 surveillance phase
- Treated with neoadjuvant chemo-radiation therapy for surveillance phase
- Synchronous colorectal and non-colorectal cancer diagnosed around surgery (except skin cancer other than melanoma) for surveillance phase
- Other cancers within 3 years from screening, excluding colorectal and certain skin cancers for surveillance phase
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From preoperative period to 20-30 days after surgery
Participants provide blood samples before and after surgery, and tissue samples are collected from the resected tumor for analysis.
2 visits (blood samples before and 20-30 days after surgery)
Duration - Up to 3 years after surgery
Participants are monitored with blood samples collected after adjuvant chemotherapy and during standard-of-care surveillance to assess minimal residual disease and recurrence.
Blood sampling visits at approximately 14-30 days post-chemotherapy, and at months 8, 12, 16, 20, 24, 30, and 36 postoperatively
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
C
Christina Demuth, PhD
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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