Status:
RECRUITING
GUIDE.MRD-01-CRC: Clinical Validation and Benchmarking of Top Performing CtDNA Diagnostics - Colorectal Cancer
Lead Sponsor:
Claus Lindbjerg Andersen
Collaborating Sponsors:
Medical University of Graz
University Medical Centre of Montpellier
Conditions:
Colorectal Cancer Stage III
Liver Metastasis Colon Cancer
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed Description
GUIDE.MRD-01-CRC is a part of WP3 of the overarching GUIDE.MRD project. Each study chair has a local clinical trial protocol where patients are recruited. After the end of recruitment, samples will be...
Eligibility Criteria
Inclusion
- Colorectal cancer stage III
- 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
- 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
Key Trial Info
Start Date :
August 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2031
Estimated Enrollment :
590 Patients enrolled
Trial Details
Trial ID
NCT06111105
Start Date
August 1 2023
End Date
July 31 2031
Last Update
March 30 2025
Active Locations (15)
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1
Abteilung für Onkologie, Medizinische Universität Graz
Graz, Styria, Austria, 8010
2
Ordenskrankenhaus Graz Mitte
Graz, Styria, Austria, 8010
3
Bispebjerg Hospital
Copenhagen, Capital Region of Denmark, Denmark, 2400
4
Herlev Hospital
Herlev, Capital Region of Denmark, Denmark, 2730