Role of Immunoscore® in Stage II-III Colorectal Cancer

Study Overview
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Brief Summary
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The proposed study is a bidirectional analytical study, composed of a retrospective and a prospective cohorts. Patients with stage II - III colorectal cancer undergoing oncological surgery will be analyzed. The study will include a convenience sample of 100 individuals. Fifty cases will be included retrospectively and fifty prospectively. The study aims to evaluate the benefit of using the Immunoscore test as a predictor of recurrence in patients with operated stage II-III colon tumors. It will also be evaluated the impact on oncologic decision and costs.

Official Title
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Role of Immunoscore® in Stage II-III Colorectal Cancer

Conditions
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Colon Adenocarcinoma

Intervention / Treatment
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* Diagnostic Test: Immunoscore Colon Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Anatomopathological diagnosis of colorectal adenocarcinoma Stage II - III (AJCC 8th edition) Patient undergoing surgery with curative intent Exclusion Criteria: Current or previous diagnosis (within the last 5 years) of another invasive primary malignant neoplasm, with the exception of non-melanoma skin neoplasm Presence of distant metastatic disease evidenced in imaging tests
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Immunoscore Colon Test|Immunoscore® is a tissue-based immune test that measures the host's immune response at the site of the tumor. It is performed on formalin-fixed paraffin-embedded (FFPE) tumor tissue samples from resections of localized colon cancer. The test uses whole slide imaging and artificial intelligence algorithms for assessment of the type, density, and location of T cells in FFPE tumor sections to determine an individual Immunoscore® for each patient.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumour recurrence | Impact of Immunoscore stratification on tumor recurrence at 2 years | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival (DFS) | Impact of Immunoscore stratification on DFS at 5 years | 5 years | 
| Overall survival (OS) | Impact of Immunoscore stratification on OS at 5 years | 5 years | 
| DFS acoording tumor side | Impact of Immunoscore stratification on DFS in right and left tumors at 3 years | 3 years | 
| OS acoording tumor side | Impact of Immunoscore stratification on OS in right and left tumors at 3 years | 3 years | 
| Indication of adjuvant therapy | Percentage of patients who had an indication for adjuvant therapy through the evaluation of medical prescriptions | 6 months | 
| Biomarker measurements | Correlation of Immunoscore stratification with the KRAS, NRAS and BRAF status | 6 months | 
| Possible economic impact | Difference in monetary value due to Immuno Score stratification and chemotherapy indication | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, colon carcinoma, immunoscore, immune response, predictive markers, prognostic markers, tumour microenvironment