Actively Recruiting

Age: 18Years +
All Genders
NCT06076811

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered 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

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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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