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.

Evaluate the patient care recommandation induced by the IMMUNOSCORE® result

Study Overview

• Status: Recruiting
• Conditions: Non Metastatic Colorectal Cancer
• Intervention / Treatment: Diagnostic test: IMMUNOSCORE®

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cécile BIELMANN; Phone Number: 04 88 73 10 70; Email: cbielmann@hopital-saint-joseph.fr

Study Locations

• France
  • Marseille, France, 13008
    • Recruiting
    • Hôpital Saint Joseph
    • Contact: Hervé PERRIER
  • Marseille, France, 13003
    • Not yet recruiting
    • Hôpital Européen
    • Contact: yves rinaldi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IMMUNOSCORE®	Diagnostic test: IMMUNOSCORE®; recommendation for patient care according to the result of the IMMUNOSCORE®

What is the study measuring?

Primary Outcome Measures

Outcome 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 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

Collaborators and Investigators

• Sponsor: Hospital St. Joseph, Marseille, France
• Investigators: Principal Investigator: Hervé Perrier, M.D, Hôpital Saint Joseph Marseille; Principal Investigator: Yves RINALDI, M.D, Hôpital Européen Marseille

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Anticipated): April 1, 2028
• Study Completion (Anticipated): April 1, 2028

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Recurrence
• Other Study ID Numbers: PPC-IS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No