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Recruiting Observational

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

NCT06111105 · tracked via the Priya Life Science France tracker
Sponsor
Claus Lindbjerg Andersen
Phase
Observational
Started
2023-08-01
Last updated
2026-05-04

Condition(s) studied

Colorectal Cancer Stage IIILiver Metastasis Colon Cancer

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Collection of clinical plasma samples at relevant time points — 8 months after end of recruitment
    For head-to-head performance assessment and benchmarking of ctDNA diagnostics

Trial sites (15)

FacilityCityRegionStatus
Abteilung für Onkologie, Medizinische Universität Graz Graz Styria Recruiting
Ordenskrankenhaus Graz Mitte Graz Styria Recruiting
Bispebjerg Hospital Copenhagen Capital Region of Denmark Recruiting
Herlev Hospital Herlev Capital Region of Denmark Not Yet Recruiting
Aarhus University Hospital Aarhus Central Jutland Recruiting
Gødstrup Hospital Herning Central Jutland Recruiting
Regional Hospital Horsens Horsens Central Jutland Recruiting
Regional Hospital Randers Randers Central Jutland Recruiting
Regional Hospital Viborg Viborg Central Jutland Recruiting
Aalborg University Hospital Aalborg North Denmark Recruiting
Odense University Hospital Odense The Region of Southern 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 Recruiting
Universitätsklinikum Hamburg-Eppendorf Hamburg Free and Hanseatic City of Hamburg Recruiting
Karolinska University Hospital Huddinge Stockholm County Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06111105 on ClinicalTrials.gov ↗ ← All trials in France