French Assessment of MRD by Liquid Biopsies in Stage III CRC Patients (FRENCH.MRD.CRC)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier

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.

FRENCH-MRD-CRC is the French study of the european GUIDE.MRD project.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient 18 years or older.

Scheduled for curative intent resection surgery (including "compromised" curative resections).

Disqualifiers

Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome.

Verified distant metastases.

Malignant colorectal polyps diagnosed after polypectomy.

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.

Trial population

PART All patients with resected stage I to III CRC PART II Patients with stage III CRC with adjuvant chemotherapy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood sample/lliquid biopsy

    Biological/Vaccine

    ctDNA analysis

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: Stage III colorectal cancer patients1 intervention

Trial outcomes

Primary outcomes

1

3-year disease-free survival (DFS)

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.

Time frame
3 years after end of recruitment

Secondary outcomes

1

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)

Time frame
3 years after end of recruitment
2

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)

Time frame
3 years after end of recruitment
3

Positive predictive value of the ctDNA diagnostics

The predictive value of a positive test or positive predictive value (PPV): PPV = TP/(TP+FP).

Time frame
3 years after end of recruitment
4

Negative predictive value of the ctDNA diagnostics

The predictive value of a negative test or negative predictive value (NPV): NPV =TN/(TN+FN).

Time frame
3 years after end of recruitment

Other outcomes

Sponsors and contacts

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