Recruiting

NCT Number: NCT04938986

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

Evaluate the patient care recommandation induced by the IMMUNOSCORE® result

Recruiting

Interested in participating?

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Key information

Conditions

Non Metastatic Colorectal Cancer

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Saint Joseph, Marseille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IMMUNOSCORE®

Diagnostic Test

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

Primary outcomes

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

Replication error (RER) phenotype

Time frame: 6 and 9 months

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

Time frame: 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

Time frame: 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)

Time frame: 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Cécile BIELMANN

CONTACT

[email protected]

04 88 73 10 70

Sponsors and collaborators

Lead sponsor

Hospital St. Joseph, Marseille, France

Other

Registry information

Official study 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.

Important dates

Study start: 2022
Primary completion: 2028
Study completion: 2028
First posted: Jun 25, 2021
Registry last updated: Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.