GUIDE.MRD-01-CRC: Clinical Validation and Benchmarking of Top Performing ctDNA Diagnostics - Colorectal Cancer

NCT06111105 | Recruiting

• 1 other identifier: GUIDE.MRD-01-CRC
• Study Type: observational
• Target: 590
• Locations: 5 countries
• Sites: 15

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 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

Colorectal Cancer Stage III; Liver Metastasis Colon Cancer

Keywords

Circulating tumor DNA; ctDNA diagnostics; Minimal residual disease

Outcome Measures

Primary Outcomes (1)

• Collection of clinical plasma samples at relevant time points

  For head-to-head performance assessment and benchmarking of ctDNA diagnostics

  8 months after end of recruitment

Secondary Outcomes (3)

• The 3-year recurrence-free survival

  3 years after end of recruitment

• Lead time between ctDNA detection and clinical recurrence

  3 years after end of recruitment

• Prognostic value of ctDNA analysis at relevant time points

  3 years after end of recruitment

Study Arms (2)

Colorectal cancer stage III

Colorectal cancer liver metastasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Colorectal cancer stage III: patient with stage III colorectal cancer treated with curative-intent surgery and adjuvant chemotherapy Colorectal cancer liver metastasis: patient with colorectal cancer liver metastasis

You may qualify if:

• 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

You may not qualify if:

• 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
• Colorectal cancer liver metastasis
• Planned for curative-intent treatment
• Performance status 0-1
• Liver cirrhosis
• Extrahepatic metastases

Sponsors & Collaborators

• Medical University of Graz: collaborator
• University Medical Centre of Montpellier: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• Karolinska Institutet: collaborator
• Claus Lindbjerg Andersen: lead
• University of Aarhus: collaborator

Study Sites (15)

Abteilung für Onkologie, Medizinische Universität Graz

Graz, Styria, 8010, Austria

RECRUITING

Ordenskrankenhaus Graz Mitte

Graz, Styria, 8010, Austria

RECRUITING

Bispebjerg Hospital

Copenhagen, Capital Region of Denmark, 2400, Denmark

RECRUITING

Herlev Hospital

Herlev, Capital Region of Denmark, 2730, Denmark

NOT YET RECRUITING

Aarhus University Hospital

Aarhus, Central Jutland, 8000, Denmark

RECRUITING

Gødstrup Hospital

Herning, Central Jutland, 7400, Denmark

RECRUITING

Regional Hospital Horsens

Horsens, Central Jutland, 8700, Denmark

RECRUITING

Regional Hospital Randers

Randers, Central Jutland, 8930, Denmark

RECRUITING

Regional Hospital Viborg

Viborg, Central Jutland, 8800, Denmark

RECRUITING

Aalborg University Hospital

Aalborg, North Denmark, 9000, Denmark

RECRUITING

Odense University Hospital

Odense, The Region of Southern Denmark, 5000, Denmark

RECRUITING

LCCRH (Laboratoire Cellules Circulantes Rares Humaines) - CHU de Montpellier

Montpellier, 34295, France

RECRUITING

Department of General-, Visceral- and Thoracic Surgery, University Medical Center Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

RECRUITING

Karolinska University Hospital

Huddinge, Stockholm County, 14183, Sweden

RECRUITING

Related Links

• Webpage of the GUIDE.MRD project

Biospecimen

Retention: SAMPLES WITH DNA

Full blood samples processed into plasma, buffy coat, and serum Formalin-fixed paraffin-embedded tumor tissue

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ellen Heitzer, PhD

  Medical University of Graz

  STUDY CHAIR

• Klaus Pantel, MD

  Universitätsklinikum Hamburg-Eppendorf

  STUDY CHAIR

• Catherine Alix-Panabiéres, PhD

  University Medical Centre of Montpellier

  STUDY CHAIR

• Matthias Löhr, MD

  Karolinska Institutet

  STUDY CHAIR

• Claus L Andersen, PhD

  Aarhus University Hospital

  STUDY DIRECTOR

Central Study Contacts

Claus L Andersen, PhD

CONTACT

+45 7845 5319; cla@clin.au.dk

Mads H Rasmussen, PhD

CONTACT

+45 7845 5314; mads.heilskov@clin.au.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 1, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2031
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

FR (1); SE (1); DK (9); AU (2); DE (2)