Evaluating blood tests for detecting residual colorectal cancer

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 validate and benchmark various circulating tumor DNA (ctDNA) diagnostics for colorectal cancer, particularly focusing on patients with stage III disease. By analyzing blood samples from patients who have undergone curative surgery, the study seeks to determine which ctDNA tests are most effective in predicting treatment needs and monitoring for residual disease. The GUIDE.MRD consortium, comprising experts from multiple institutions, will collect and analyze these samples to establish reliable standards for ctDNA diagnostics in clinical settings. The ultimate goal is to enhance personalized treatment strategies for colorectal cancer patients.

Why it matters

Who can join: the full rules

Colorectal cancer stage III

Inclusion Criteria:

* Colorectal cancer, UICC stage III
* Has received curative-intent resection and is a candidate for adjuvant chemotherapy
* Patient able to understand and sign written informed consent

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
* Not treated with adjuvant chemotherapy despite indication (incomplete treatment not included)
* Treated with neoadjuvant chemo-radiation therapy
* No tissue sample available for the project, or tumor content in the tissue sample is \<20%
* 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

Colorectal cancer liver metastasis

Inclusion Criteria:

* Colorectal cancer liver metastasis
* Planned for curative-intent treatment
* Performance status 0-1

Exclusion Criteria:

* Liver cirrhosis
* Extrahepatic metastases
* Other cancer within the last 5 years
* Intervention not performed with curative intent
* No tissue available from CRLM or primary tumor

Where it's running

• Abteilung für Onkologie, Medizinische Universität Graz
  Graz, Styria, Austria Recruiting
• Ordenskrankenhaus Graz Mitte
  Graz, Styria, Austria Recruiting
• 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

Study contacts

• 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.