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

Not Applicable

Recruiting

• Conditions: Non Metastatic Colorectal Cancer
• Interventions: Diagnostic Test: IMMUNOSCORE®

• Registration Number: NCT04938986
• Lead Sponsor: Hospital St. Joseph, Marseille, France

Brief Summary

Evaluate the patient care recommandation induced by the IMMUNOSCORE® result

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-25
• Status Verified: 2022-04
• Study Start: 2022-04-04
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-13
• Primary Completion: 2028-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMMUNOSCORE®	IMMUNOSCORE®	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (2)

Hôpital Européen; 🇫🇷 Marseille, France

Hopital Saint Joseph; 🇫🇷 Marseille, France