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.
FRENCH.MRD.CRLM is the French study and part of the european GUIDE.MRD project.
Patient 18 years or older.
Colorectal cancer liver metastasis or metastases, according to the assessment of the MDT.
Metachronous and synchronous metastases will be included, as long as treatment intention of metastases resection is curative. In case of rare instances, where the liver metastases is removed before surgery of the primary tumor, postOP ctDNA is collected when the patient is considered completely tumor-free, i.e. after complete surgery of both the liver metastases and the primary tumor.
Treatment is planned with curative intent (patients treated with RFA can be included, BUT in these cases a tissue sample from the primary CRC tumor is a requisite)
Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome.
Extrahepatic metastases
Malignant colorectal polyps diagnosed after polypectomy.
Synchronous colorectal and non-colorectal cancer diagnosed per operative (except skin cancer other than melanoma)
Patients with resectable colorectal liver metastasis
Cohort
Prospective
Blood sample/Liquid biopsy
Biological/VaccinectDNA analysis
3-year disease free survival
Disease-free survival was defined as the time between the date of the baseline blood sampling/inclusion and the date of the first event among or recurrence or death from any cause.
Sensitivity (Se) of the ctDNA diagnostics
Sensitivity (Se) of the ctDNA diagnostics is calculated in subjects with a 3-year recurrence: Se = TP/(TP+FN) (a positive reference test)
Specificity (Sp) of the ctDNA diagnostics
Specificity (Sp) of the ctDNA diagnostics is calculated in subjects without a 3-year recurrence: Sp = TN/(TN+FP) (a negative reference test)
Positive predictive value of the ctDNA diagnostics
The predictive value of a positive test or positive predictive value (PPV): PPV = TP/(TP+FP).
Negative predictive value of the ctDNA diagnostics
The predictive value of a negative test or negative predictive value (NPV): NPV =TN/(TN+FN).
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