Interest of the Immunoscore® as a Post-operative Complementary Tool for the Detection of the Risk of Recurrence in Patients With Nonmetastatic Colorectal Cancer

Study Overview
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Brief Summary
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Evaluate the patient care recommandation induced by the IMMUNOSCORE® result

Official Title
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Interest of the Immunoscore® as a Post-operative Complementary Tool for the Detection of the Risk of Recurrence in Patients With Nonmetastatic Colorectal Cancer : Prospective Cohort Comparing the Recommandation for Patient Care According to the Immunoscore® With the Standard Care Decision.

Conditions
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Non Metastatic Colorectal Cancer

Intervention / Treatment
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* Diagnostic Test: IMMUNOSCORE®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18 and 80 inclusive; histologically confirmed colon adenocarcinoma; having undergone a curative resection of stage I, II or III colorectal cancer; diagnosed T1 / T2 / T3 / T4 and N0 / N1 / N2; eligible to receive 6 months of adjuvant chemotherapy; having given free, informed and written consent; agreeing to the use of a tumor sample for research purposes; being affiliated to a social security system. Exclusion Criteria: pregnant or breastfeeding women legal incapacity or physical, psychological, social or geographical conditions preventing the patient from signing the consent or completing the study. history of other solid tumor within 3 years before inclusion, with the exception of in-situ cancer of the cervix and skin cancers (basal or squamous) treated and controlled person subject to a safeguard measure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMMUNOSCORE®<br> | Diagnostic Test: IMMUNOSCORE®<br>* recommendation for patient care according to the result of the IMMUNOSCORE®<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cases where the recommendations for patient care according to the Immunoscore® are considered beneficial compared to the standard care decision |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Replication error (RER) phenotype | Number of cases where the Immunoscore® resultat is inconsistent with the RER phenotype | 6 and 9 months | 
| KRAS, NRAS and BRAF mutations | Number of cases where the Immunoscore® resultat is inconsistent with the KRAS, NRAS and BRAF mutations | 6 and 9 months | 
| Ratio of ciruclating tumor DNA level | Number of cases where the Immunoscore® resultat is inconsistent with the ratio of ciruclating tumor DNA level | 6 and 9 months | 
| Actual survival (patient alive without recurrence, alive with recurrence, dead) | Number of cases where the Immunoscore® resultat is inconsistent with the actual survival | 5 years |