Recruiting 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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IMMUNOSCORE®.
- Who it may be relevant to
- Registry conditions: Non Metastatic Colorectal Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
Evaluate the patient care recommandation induced by the IMMUNOSCORE® result
Interventions
- Diagnostic test IMMUNOSCORE®
recommendation for patient care according to the result of the IMMUNOSCORE®
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 [Time frame: 5 years]
Secondary outcome measures (4)
- Replication error (RER) phenotype [Time frame: 6 and 9 months]
- KRAS, NRAS and BRAF mutations [Time frame: 6 and 9 months]
- Ratio of ciruclating tumor DNA level [Time frame: 6 and 9 months]
- Actual survival (patient alive without recurrence, alive with recurrence, dead) [Time frame: 5 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 2 centers
- Hôpital Européen — Marseille
- Hopital Saint Joseph — Marseille
Identifiers
NCT: NCT04938986 · PPC-IS