Actively Recruiting

Age: 18Years +
All Genders
NCT06111105

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

Led by Claus Lindbjerg Andersen · Updated on 2026-05-04

590

Participants Needed

15

Research Sites

417 weeks

Total Duration

On this page

Sponsors

C

Claus Lindbjerg Andersen

Lead Sponsor

M

Medical University of Graz

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Colorectal cancer, UICC stage III
  • Received curative-intent surgery and candidate for adjuvant chemotherapy
  • Able to understand and sign informed consent
  • Colorectal cancer liver metastasis
  • Planned for curative-intent treatment
  • Performance status 0-1
Not Eligible

You will not qualify if you...

  • 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
  • Treated with neoadjuvant chemo-radiation therapy
  • No tissue sample available or tumor content <20%
  • Synchronous colorectal and non-colorectal cancer diagnosed per operative (except skin cancer other than melanoma)
  • Other cancers (excluding colorectal or certain skin cancers) within 3 years
  • Unlikely to comply with the study protocol
  • Liver cirrhosis
  • Extrahepatic metastases
  • Other cancer within last 5 years
  • Intervention not performed with curative intent
  • No tissue available from liver metastases or primary tumor

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

Abteilung für Onkologie, Medizinische Universität Graz

Graz, Styria, Austria, 8010

Actively Recruiting

2

Ordenskrankenhaus Graz Mitte

Graz, Styria, Austria, 8010

Actively Recruiting

3

Bispebjerg Hospital

Copenhagen, Capital Region of Denmark, Denmark, 2400

Actively Recruiting

4

Herlev Hospital

Herlev, Capital Region of Denmark, Denmark, 2730

Not Yet Recruiting

5

Aarhus University Hospital

Aarhus, Central Jutland, Denmark, 8000

Actively Recruiting

6

Gødstrup Hospital

Herning, Central Jutland, Denmark, 7400

Actively Recruiting

7

Regional Hospital Horsens

Horsens, Central Jutland, Denmark, 8700

Actively Recruiting

8

Regional Hospital Randers

Randers, Central Jutland, Denmark, 8930

Actively Recruiting

9

Regional Hospital Viborg

Viborg, Central Jutland, Denmark, 8800

Actively Recruiting

10

Aalborg University Hospital

Aalborg, North Denmark, Denmark, 9000

Actively Recruiting

11

Odense University Hospital

Odense, The Region of Southern Denmark, Denmark, 5000

Actively Recruiting

12

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

Montpellier, France, 34295

Actively Recruiting

13

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

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

Actively Recruiting

14

Universitätsklinikum Hamburg-Eppendorf

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

Actively Recruiting

15

Karolinska University Hospital

Huddinge, Stockholm County, Sweden, 14183

Actively Recruiting

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Research Team

C

Claus L Andersen, PhD

CONTACT

M

Mads H Rasmussen, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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