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NCT06111105Recruiting

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 · Last updated 4 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
590 (estimated)
First submitted
26 Oct 2023
Start date
1 Aug 2023
Primary completion date
31 Jul 2026
Lead sponsor
Claus Lindbjerg Andersen
NCT number
NCT06111105

What you commit to

  • Study type: Observational
  • Planned participants: 590
  • From 1 Aug 2023 to the primary completion date, 31 Jul 2026
  • 15 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Not treated with adjuvant chemotherapy despite indication (incomplete treatment not included)
  • Treated with neoadjuvant chemo-radiation therapy

Other illness

  • Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome
  • Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
  • 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
  • Other cancer within the last 5 years

Other

  • Verified distant metastases
  • No tissue sample available for the project, or tumor content in the tissue sample is \<20%
  • Liver cirrhosis
  • Extrahepatic metastases
  • Intervention not performed with curative intent
  • No tissue available from CRLM or primary tumor

Who the study is looking for

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

Criteria the registry did not label

  • Colorectal cancer stage III

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Abteilung für Onkologie, Medizinische Universität Graz
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GrazAustriaRecruiting
Ordenskrankenhaus Graz Mitte
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GrazAustriaRecruiting
Department of General-, Visceral- and Thoracic Surgery, University Medical Center Hamburg-Eppendorf
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HamburgGermanyRecruiting
Universitätsklinikum Hamburg-Eppendorf
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HamburgGermanyRecruiting
Aalborg University Hospital
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AalborgDenmarkRecruiting
Aarhus University Hospital
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AarhusDenmarkRecruiting
Bispebjerg Hospital
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CopenhagenDenmarkRecruiting
Herlev Hospital
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HerlevDenmarkNot yet recruiting
Gødstrup Hospital
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HerningDenmarkRecruiting
Regional Hospital Horsens
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HorsensDenmarkRecruiting
Odense University Hospital
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OdenseDenmarkRecruiting
Regional Hospital Randers
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RandersDenmarkRecruiting
Regional Hospital Viborg
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ViborgDenmarkRecruiting
LCCRH (Laboratoire Cellules Circulantes Rares Humaines) - CHU de Montpellier
Coordinator of this site? Confirm its status
MontpellierFranceRecruiting
Karolinska University Hospital
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HuddingeSwedenRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.