Assessing minimal residual disease in colorectal cancer using blood tests

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Bispebjerg Hospital
  Copenhagen, Capital Region of Denmark, Denmark 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.