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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHospital St. Joseph, Marseille, France

About this trial

Evaluate the patient care recommandation induced by the IMMUNOSCORE® result

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • IMMUNOSCORE®

    Diagnostic test

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: IMMUNOSCORE®Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of cases where the recommendations for patient care according to the Immunoscore® are considered beneficial compared to the standard care decision

Time frame
5 years

Secondary outcomes

1

Replication error (RER) phenotype

Number of cases where the Immunoscore® resultat is inconsistent with the RER phenotype

Time frame
6 and 9 months
2

KRAS, NRAS and BRAF mutations

Number of cases where the Immunoscore® resultat is inconsistent with the KRAS, NRAS and BRAF mutations

Time frame
6 and 9 months
3

Ratio of ciruclating tumor DNA level

Number of cases where the Immunoscore® resultat is inconsistent with the ratio of ciruclating tumor DNA level

Time frame
6 and 9 months
4

Actual survival (patient alive without recurrence, alive with recurrence, dead)

Number of cases where the Immunoscore® resultat is inconsistent with the actual survival

Time frame
5 years

Other outcomes

Sponsors and contacts

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