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

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.

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04938986

Enrollment

100

Registered

2021-06-25

Start date

2022-04-04

Completion date

2028-04-30

Last updated

2022-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Metastatic Colorectal Cancer

Brief summary

Evaluate the patient care recommandation induced by the IMMUNOSCORE® result

Interventions

DIAGNOSTIC_TESTIMMUNOSCORE®

recommendation for patient care according to the result of the IMMUNOSCORE®

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Measure	Time frame	Description
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

Countries

France

Contacts

Primary ContactCécile BIELMANN

cbielmann@hopital-saint-joseph.fr04 88 73 10 70

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026