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

NCT ID: NCT04938986

Last Updated: 2022-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-04

Study Completion Date

2028-04-30

Brief Summary

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Evaluate the patient care recommandation induced by the IMMUNOSCORE® result

Detailed Description

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Conditions

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Non Metastatic Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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IMMUNOSCORE®

Group Type EXPERIMENTAL

IMMUNOSCORE®

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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IMMUNOSCORE®

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital St. Joseph, Marseille, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hervé PERRIER, M.D

Role: PRINCIPAL_INVESTIGATOR

Hopital Saint Joseph Marseille

Yves RINALDI, M.D

Role: PRINCIPAL_INVESTIGATOR

Hopital Européen Marseille

Locations

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Hôpital Européen

Marseille, , France

Site Status NOT_YET_RECRUITING

Hopital Saint Joseph

Marseille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Cécile BIELMANN

Role: CONTACT

04 88 73 10 70

Facility Contacts

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Yves RINALDI

Role: primary

Hervé PERRIER

Role: primary

Other Identifiers

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PPC-IS

Identifier Type: -

Identifier Source: org_study_id

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