GUIDE.MRD-01-CRC: Clinical Validation and Benchmarking of Top Performing ctDNA Diagnostics - Colorectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorClaus Lindbjerg Andersen
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
590 Participants
are grouped into 2 trial groupsGroup A: Colorectal cancer stage III
Group B: Colorectal cancer liver metastasis
Trial outcomes
Primary outcomes
1
Collection of clinical plasma samples at relevant time points
For head-to-head performance assessment and benchmarking of ctDNA diagnostics
Time frame
8 months after end of recruitmentSecondary outcomes
1
The 3-year recurrence-free survival
Time frame
3 years after end of recruitment2
Lead time between ctDNA detection and clinical recurrence
Time frame
3 years after end of recruitment3
Prognostic value of ctDNA analysis at relevant time points
Time frame
3 years after end of recruitmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Claus Lindbjerg Andersen
Lead sponsor
University of Aarhus
Sponsor institution
Medical University of Graz
Collaborator
University Medical Centre of Montpellier
Collaborator
Universitätsklinikum Hamburg-Eppendorf
Collaborator
University of Aarhus
Collaborator
Karolinska Institutet
Collaborator
Source ClinicalTrials.gov