Evaluating blood tests for detecting residual colorectal cancer
GUIding Multi-moDal thErapies Against MRD by Liquid Biopsies in Colorectal Cancer - GUIDE.MRD-01-CRC
University of Aarhus · NCT06111105
This study is testing different blood tests to see which ones best help stage III colorectal cancer patients find out if they need more treatment after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 590 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 15 sites (Graz, Styria and 14 other locations) |
| Trial ID | NCT06111105 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with colorectal cancer stage III who have undergone curative-intent surgery and are candidates for adjuvant chemotherapy.
Not a fit: Patients with hereditary colorectal cancer syndromes, inflammatory bowel disease, or those with verified distant metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate treatment decisions for colorectal cancer patients, potentially improving outcomes and reducing unnecessary treatments.
How similar studies have performed: Other studies have shown promise in using ctDNA diagnostics for cancer monitoring, but this specific benchmarking approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Graz, Styria and 14 other locations
- 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)
- 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)
- LCCRH (Laboratoire Cellules Circulantes Rares Humaines) - CHU de Montpellier — Montpellier, France (RECRUITING)
- Department of General-, Visceral- and Thoracic Surgery, University Medical Center Hamburg-Eppendorf — Hamburg, Free and Hanseatic City of Hamburg, Germany (RECRUITING)
- Universitätsklinikum Hamburg-Eppendorf — Hamburg, Free and Hanseatic City of Hamburg, Germany (RECRUITING)
- Karolinska University Hospital — Huddinge, Stockholm County, Sweden (RECRUITING)
Study contacts
- 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.
Conditions: Colorectal Cancer Stage III, Liver Metastasis Colon Cancer, Circulating tumor DNA, ctDNA diagnostics, Minimal residual disease