Assessing minimal residual disease in colorectal cancer using blood tests
Danish Assessment of Minimal Residual Disease by Liquid Biopsies
This study is testing if a blood test for cancer DNA can help doctors find out which colorectal cancer patients are at risk of their cancer coming back after surgery and if they need extra treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 10 sites (Copenhagen, Capital Region of Denmark and 9 other locations) |
| Trial ID | NCT06076811 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the prognostic value of circulating tumor DNA (ctDNA) in patients with colorectal cancer who have undergone curative-intent surgery. By analyzing blood samples for ctDNA presence after surgery, the study seeks to identify patients at high risk of cancer recurrence and determine the effectiveness of adjuvant chemotherapy. The research will compare ctDNA results with traditional prognostic factors to enhance risk stratification and improve patient outcomes. The ultimate goal is to integrate ctDNA analysis into clinical practice for better management of colorectal cancer.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with clinical tumor stage I-III colorectal cancer scheduled for curative-intent surgery.
Not a fit: Patients with hereditary colorectal cancer syndromes, inflammatory bowel disease, or verified distant metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate risk assessments and tailored treatment plans for colorectal cancer patients, potentially reducing recurrence rates.
How similar studies have performed: Previous studies have shown promising results using ctDNA for monitoring cancer recurrence, indicating that this approach is gaining traction in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
DANISH.MRD part I - Surgery Inclusion Criteria: * 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). Exclusion Criteria: * 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 Inclusion Criteria: * 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). Exclusion Criteria: * 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.
Where this trial is running
Copenhagen, Capital Region of Denmark and 9 other locations
- Bispebjerg Hospital — Copenhagen, Capital Region of Denmark, Denmark (Recruiting)
- Herlev Hospital — Herlev, Capital Region of Denmark, Denmark (Not_yet_recruiting)
- Aarhus University Hospital — Aarhus, Central Jutland, Denmark (Recruiting)
- Gødstrup Hospital — Herning, Central Jutland, Denmark (Recruiting)
- Regional Hospital Horsens — Horsens, Central Jutland, Denmark (Recruiting)
- Regional Hospital Randers — Randers, Central Jutland, Denmark (Recruiting)
- Regional Hospital Viborg — Viborg, Central Jutland, Denmark (Recruiting)
- Aalborg University Hospital — Aalborg, North Denmark, Denmark (Recruiting)
- Odense University Hospital — Odense, The Region of Southern Denmark, Denmark (Recruiting)
- Vejle Hospital — Vejle, Denmark (Recruiting)
Study contacts
- Principal investigator: Claus L Andersen, PhD — Aarhus University Hospital
- Study coordinator: Claus L Andersen, PhD
- Email: cla@clin.au.dk
- Phone: +45 7845 5319
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.