Using Immunoscore® to Assess Recurrence Risk in Nonmetastatic Colorectal Cancer Patients
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.
This study is testing if the Immunoscore® can help doctors predict the chance of cancer coming back in adults aged 18 to 80 who have had surgery for early-stage colorectal cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hospital St. Joseph, Marseille, France Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Marseille and 1 other locations) |
| Trial ID | NCT04938986 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Immunoscore® as a post-operative tool to detect the risk of recurrence in patients with nonmetastatic colorectal cancer. It focuses on patients aged 18 to 80 who have undergone curative resection for stage I, II, or III colon adenocarcinoma. The study aims to analyze how the Immunoscore® results can influence patient care recommendations and treatment decisions. Participants will provide tumor samples for research purposes and must consent to the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with histologically confirmed nonmetastatic colon adenocarcinoma who have undergone curative surgery.
Not a fit: Patients with a history of other solid tumors within the last three years or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized treatment plans and improved outcomes for colorectal cancer patients.
How similar studies have performed: While the Immunoscore® is a novel approach, similar studies have shown promise in improving risk assessment for cancer recurrence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Marseille and 1 other locations
- Hôpital Européen — Marseille, France (Not_yet_recruiting)
- Hopital Saint Joseph — Marseille, France (Recruiting)
Study contacts
- Principal investigator: Hervé PERRIER, M.D — Hopital Saint Joseph Marseille
- Study coordinator: Cécile BIELMANN
- Email: cbielmann@hopital-saint-joseph.fr
- Phone: 04 88 73 10 70
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.