DANISH.MRD: Danish Assessment of Minimal Residual Disease by Liquid Biopsies
Danish Assessment of Minimal Residual Disease by Liquid Biopsies
1 other identifier
observational
1,600
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2023
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2023
CompletedFirst Submitted
Initial submission to the registry
October 4, 2023
CompletedFirst Posted
Study publicly available on registry
October 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2030
February 4, 2026
February 1, 2026
5 years
October 4, 2023
February 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The prognostic value of ctDNA status
Especially, the association between 3-year disease-free survival and ctDNA status after surgery and after adjuvant chemotherapy
3 years after surgery
Secondary Outcomes (6)
Ranking of commercial ctDNA diagnostics
3 years after surgery
Change in ctDNA levels after adjuvant chemotherapy
3 years after surgery
Lead time between molecular and clinical recurrence
3 years after surgery
Correlation between ctDNA analysis and findings on CT scans
3 years after surgery
Prognostic power of ctDNA at the time point of an indeterminate CT scan
3 years after surgery
- +1 more secondary outcomes
Eligibility Criteria
DANISH.MRD part I - Surgery Patients with colorectal cancer clinical stage I-III scheduled for curative-intent resectional surgery. DANISH.MRD part I - Surveillance Patients participating in DANISH.MRD part 1, and pathological stage III colorectal cancer, and candidates for adjuvant chemotherapy.
You may qualify if:
- 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).
You may not qualify if:
- 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
- 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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aarhus University Hospitalcollaborator
Study Sites (10)
Bispebjerg Hospital
Copenhagen, Capital Region of Denmark, 2400, Denmark
Herlev Hospital
Herlev, Capital Region of Denmark, 2730, Denmark
Aarhus University Hospital
Aarhus, Central Jutland, 8000, Denmark
Gødstrup Hospital
Herning, Central Jutland, 7400, Denmark
Regional Hospital Horsens
Horsens, Central Jutland, 8700, Denmark
Regional Hospital Randers
Randers, Central Jutland, 8930, Denmark
Regional Hospital Viborg
Viborg, Central Jutland, 8800, Denmark
Aalborg University Hospital
Aalborg, North Denmark, 9000, Denmark
Odense University Hospital
Odense, The Region of Southern Denmark, 5000, Denmark
Vejle Hospital
Vejle, 7100, Denmark
Biospecimen
Tumor tissue Normal tissue Whole blood (processed to plasma, buffycoat and serum) Dried blood spots.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claus L Andersen, PhD
Aarhus University Hospital
- PRINCIPAL INVESTIGATOR
Lene H Iversen, MD, DMSc
Aarhus University Hospital
- PRINCIPAL INVESTIGATOR
Kåre A Gotschalck, MD, PhD
Regionshospitalet Horsens
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2023
First Posted
October 11, 2023
Study Start
August 1, 2023
Primary Completion (Estimated)
July 30, 2028
Study Completion (Estimated)
July 30, 2030
Last Updated
February 4, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share