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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

Primary Purpose

Non Metastatic Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
IMMUNOSCORE®
Sponsored by
Hospital St. Joseph, Marseille, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non Metastatic Colorectal Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hôpital Européen
  • Hopital Saint JosephRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMMUNOSCORE®

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Replication error (RER) phenotype
Number of cases where the Immunoscore® resultat is inconsistent with the RER phenotype
KRAS, NRAS and BRAF mutations
Number of cases where the Immunoscore® resultat is inconsistent with the KRAS, NRAS and BRAF mutations
Ratio of ciruclating tumor DNA level
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)
Number of cases where the Immunoscore® resultat is inconsistent with the actual survival

Full Information

First Posted
June 22, 2021
Last Updated
April 12, 2022
Sponsor
Hospital St. Joseph, Marseille, France
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1. Study Identification

Unique Protocol Identification Number
NCT04938986
Brief Title
Interest of the Immunoscore® as a Post-operative Complementary Tool for the Detection of the Risk of Recurrence in Patients With Nonmetastatic Colorectal Cancer
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2022 (Actual)
Primary Completion Date
April 2028 (Anticipated)
Study Completion Date
April 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital St. Joseph, Marseille, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Metastatic Colorectal Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IMMUNOSCORE®
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
IMMUNOSCORE®
Intervention Description
recommendation for patient care according to the result of the IMMUNOSCORE®
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Replication error (RER) phenotype
Description
Number of cases where the Immunoscore® resultat is inconsistent with the RER phenotype
Time Frame
6 and 9 months
Title
KRAS, NRAS and BRAF mutations
Description
Number of cases where the Immunoscore® resultat is inconsistent with the KRAS, NRAS and BRAF mutations
Time Frame
6 and 9 months
Title
Ratio of ciruclating tumor DNA level
Description
Number of cases where the Immunoscore® resultat is inconsistent with the ratio of ciruclating tumor DNA level
Time Frame
6 and 9 months
Title
Actual survival (patient alive without recurrence, alive with recurrence, dead)
Description
Number of cases where the Immunoscore® resultat is inconsistent with the actual survival
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cécile BIELMANN
Phone
04 88 73 10 70
Email
cbielmann@hopital-saint-joseph.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hervé PERRIER, M.D
Organizational Affiliation
Hopital Saint Joseph Marseille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yves RINALDI, M.D
Organizational Affiliation
Hopital Européen Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Européen
City
Marseille
ZIP/Postal Code
13003
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves RINALDI
Facility Name
Hopital Saint Joseph
City
Marseille
ZIP/Postal Code
13008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hervé PERRIER

12. IPD Sharing Statement

Learn more about this trial

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

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