Clinical trial · Observational
GUIDE.MRD-01-CRC: Clinical Validation and Benchmarking of Top Performing ctDNA Diagnostics - Colorectal Cancer
GUIding Multi-moDal thErapies Against MRD by Liquid Biopsies in Colorectal Cancer - GUIDE.MRD-01-CRC
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Improving personalized cancer treatments and finding the best strategies to treat each patient relies on using new diagnostic technologies. Currently, for colorectal cancer, the methods used to decide who gets additional post-surgery treatment are suboptimal. Some patients get too much treatment, while others do not get enough. There is a new way to explore if there is any cancer left in a patient's body using circulating tumor DNA (ctDNA) detected in blood samples. This can help decide who needs more treatment after surgery. Even though many tests have been developed, it has yet to be determined which test performs best at relevant time points. The GUIDE.MRD consortium is a group of experts, including scientists, technology, and pharmaceutical companies. The consortium is working on creating a reliable standard for the ctDNA tests, validating their clinical utility, and collecting data to help decide on the best treatment for each patient. GUIDE.MRD-01-CRC is a part of the GUIDE.MRD project.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Stage III | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Liver Metastasis Colon Cancer | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Colorectal cancer stage III
- label
- Colorectal cancer liver metastasis
Primary outcomes (1)
- measure
- Collection of clinical plasma samples at relevant time points
- timeFrame
- 8 months after end of recruitment
- description
- For head-to-head performance assessment and benchmarking of ctDNA diagnostics
Secondary outcomes (3)
- measure
- The 3-year recurrence-free survival
- timeFrame
- 3 years after end of recruitment
- measure
- Lead time between ctDNA detection and clinical recurrence
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available